Gastroparesis
Conditions
Keywords
tolerability, camicinal, single dose, acetaminophen, gastric emptying, critically ill, GSK962040, pharmacokinetics, pharmacodynamics, gut motility
Brief summary
This is a multi-center, parallel group, placebo-controlled and active-compared, randomized study to assess the ability of GSK962040 to enhance the delivery of enteral feed to critically ill subjects that are predisposed to developing feeding intolerance (e.g., percentage of goal volume); enhance gastric emptying in this population; and provide preliminary evidence of the drug's effect on outcomes of therapy (length of stay in the Intensive Care Unit \[ICU\], time on ventilator, ICU acquired infections, and 60-day mortality). Other aims are evaluation of GSK962040 safety, tolerability and pharmacokinetics upon repeat dosing in a critically ill population. After meeting eligibility criteria, male and female subjects will be randomized to either receive GSK962040 (50 milligram \[mg\]) once daily (OD) via naso-gastric (NG) or orogastric (OG) feeding tube (oral solution), or placebo by the same route. If subjects develop intolerance to enteral feeding at any point up to Dose 5 of study medication (inclusive), study treatments will switch such that those originally receiving GSK962040 will receive metoclopramide (10 mg, intravenous \[iv\], every 6 hours) and those subjects originally randomized to receive placebo will receive GSK962040 (50 mg, via NG, OD). Additionally, if subjects develop intolerance prior to any treatment, they will be randomized to receive either GSK962040 (50 mg, via NG, OD) or metoclopramide (10 mg, iv, every 6 hours). The study will consist of a screening/baseline assessment, a treatment period (up to 7 days in duration), and a 4-day post treatment safety follow-up assessment. The duration of each subject's participation in the study from screening to follow-up safety assessment will be up to approximately 2 weeks. In addition, mortality will be assessed 60 days after admission to the ICU.
Interventions
DRUGGSK962040 50 mg
GSK962040 50 mg will be administered once daily enteral dose through NG tube up to 7 days.
Metoclopramide will be administered IV every 6 h
DRUGPlacebo NG
Matching placebo once daily enteral dose will be administered through NG tube up to 7 days
DRUGPlacebo IV
Placebo will be administered IV every 6 hours
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Age & Gender: Male or female between 18 and 85 years of age inclusive, at the time of obtaining the informed consent. * First admitted to participating ICU within the previous 48 hours. * Intubated and invasively mechanically ventilated * Indicated to receive early EN or are already receiving EN (subject must be on EN prior to receiving study treatment) * Have at least one of the following * Clinical evidence of cardiovascular dysfunction defined as the need for vasopressor agents (e.g. norepinephrine, epinephrine, vasopressin), \>5 microgram/kg/min of dopamine, or \>/= 50 microgram/min phenylephrine) for greater than or equal to 2 hours; * Poly-trauma with an injury severity score (ISS) \>=15 points * Acute traumatic or non-traumatic brain injury Glasgow Coma Scale (GCS) \<=12, prior to the initiation of sedation.
Exclusion criteria
* Subjects who are not expected to be in the ICU and alive for at least 48 hrs from point of screening. * Subjects with acute hepatitis (e.g. acute hepatitis B or C) or severe chronic liver disease (e.g. Child Pugh class C cirrhosis) will be excluded * Liver function tests: If Alanine aminotransferase (ALT) \>=8x upper limit of normal (ULN); OR If ALT \>5-8x ULN and bilirubin \>2\<=3 ULN or bilirubin \>3x ULN (Include only if bilirubin \<1.5xULN); OR If ALT \<=5xULN and Bilirubin \>3xULN (Include only if ALT \<=3xULN and Bilirubin \>2 \<=3xULN) * Subjects who have received a gastric prokinetic agent in the previous 12 hours (e.g., erythromycin, azithromycin, metoclopramide, domperidone). * QT duration corrected for heart rate (QTc) \>480 ms. QTcF is the recommended correction factor for all sites. If QT duration corrected for heart rate by Fridericia's formula (QTcF) is not possible to obtain or calculate, QT duration corrected for heart rate by Bazett's formula (QTcB) or machine or manual over read, may be obtained after consultation with the medical monitor. The QT correction formula used to determine inclusion and discontinuation should be the same throughout the study. * Use of strong Cyp3A4 inhibitors * Subjects who require renal replacement therapy or with an estimated glomerular filtration rate (GFR) of \<30 mL/min byCockroft-Gault calculation). * Subjects who have a history of or who have undergone major esophageal or gastric surgery on this admission (major lower abdominal surgery will not result in exclusion unless this carries a contraindication to enteral feeding). * Subjects with an absolute contraindication to enteral nutrition e.g. subjects with ongoing bowel obstruction or perforation. * Subject has a gastric pacemaker * Pregnant or lactating females * History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. * Concurrent enrollment in other interventional study involving a novel (i.e.unapproved or experimental) chemical or biopharmaceutical entity. * Previous randomization in this study * Subjects for whom the reason for admission to ICU was an overdose (deliberate or accidental; medicinal product or not). * Exclusion to re-randomization: * Subjects with an untreated pheochromocytoma. * Subjects with a past history of a seizure disorder (e.g., epilepsy) and is currently receiving anti-epileptic treatment for their seizure disorder, ongoing refractory, or sustained seizure disorder (prophylactic use for head injury/isolated new seizure maintained on anti-seizure meds in ICU acceptable). * Subjects taking drugs likely to cause extrapyramidal reactions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population | Up to Day 7 | The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis. |
| Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population | Up to Day 7 | The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance | Up to Day 7 | Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data. |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | up to 23 days | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to 23 days | SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the standard deviation (SD) was set to missing. |
| Change From Baseline in Heart Rate (HR) | Up to 23 days | HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Up to 23 days | 12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). |
| Change From Baseline in Albumin and Total Protein Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Up to 23 days | Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Hematocrit Level | Up to 23 days | Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Up to 23 days | Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Up to 23 days | Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing. |
| Time to Development of Feeding Intolerance | Up to Day 7 | Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented. |
| Average Percentage Goal Calories Delivered Prior to Development of Intolerance | Up to Day 7 | The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis. |
| Log Transformed AUC[0-60] of Acetaminophen | At Day 2 | Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC\[0-60\] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles) |
| Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) | At Day 2 | Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC\[0-60\] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles) |
| Log Transformed C60 of 3-OMG | At Day 2 | Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). |
| Derived Tmax of 3-OMG Post Intolerance | At Day 2 | Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG. |
| Percentage of Participants That Became Intolerant | Up to Day 7 | Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement. |
| GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen | Day 2 | GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed. |
| GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen | Baseline, Day 2, Day 3, Day 4 | GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed. |
| GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | Baseline, Day 2, Day 3, Day 4 | GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed. |
| GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | Baseline, Day 2, Day 3, Day 4 | GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed. |
| Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | up to 23 days | The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed. |
| Total GRV for 24 hr Period | Up to Day 7 | Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data. |
| Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance | Day 2, Day 3, Day 4, Day 7 | Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). |
| Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance | Day 2 and Day 4 | Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n \< 3. |
| Derived Tmax of GSK962040 Post Intolerance | Day 2 and Day 4 | Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n\<3. |
| Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance | Day 2 and Day 4 | Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time \[AUC(0-inf)\] was not analyzed. |
| Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance | Baseline, Day 2, Day 3, Day 4 | To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed. |
| Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | At Day 2 | Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles). |
| Average Percentage Goal Protein Delivered Prior to Development of Intolerance | Up to Day 7 | The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis. |
Countries
Australia, Canada, United States
Participant flow
Recruitment details
A total of 92 participants between 18 to 85 years of age who were admitted to Intensive Care Unit (ICU), mechanically ventilated and who received enteral nutrition (EN) were included in this study.
Pre-assignment details
The study consisted of a screening phase, a treatment period of up to 7 days and a post treatment safety follow-up of 14 days after the last dose of study medication. After performing Baseline tests eligible participants were included in the study.
Participants by arm
| Arm | Count |
|---|---|
| Baseline EN Tolerant: Placebo/Camicinal Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of placebo drug once daily via Naso-orogastric (NG) tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Camicinal 50 milligram (mg) once daily along with placebo drug every 6 hours (hrs) via Intravenous (IV) route. | 40 |
| Baseline EN Tolerant: Camicinal/Metoclopramide Participants who were tolerant to EN feeding at Baseline were randomized to receive up to 7 doses of Camicinal (GSK962040) 50 mg once daily via NG tube. Participants who developed intolerance to EN feeding at any point up to dose 5 were switched to receive Metoclopramide 10 mg every 6 hrs via IV route along with placebo drug every 6 hrs via NG route. | 44 |
| Baseline EN Intolerant: Camicinal Participants who were intolerant to EN feeding at Baseline were randomized to receive Camicinal (GSK962040) 50 mg once daily via NG tube along with placebo drug every 6 hrs via IV route. | 4 |
| Baseline EN Intolerant: Metoclopramide Participant who were intolerant to EN feeding at Baseline were randomized to receive metoclopramide 10 mg every 6 Hrs. via IV route along with placebo drug every 6 hrs via NG tube. | 4 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Other: reached stopping criteria | 6 | 5 | 1 | 0 |
| Overall Study | Physician Decision | 3 | 2 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Baseline EN Tolerant: Placebo/Camicinal | Baseline EN Tolerant: Camicinal/Metoclopramide | Baseline EN Intolerant: Camicinal | Baseline EN Intolerant: Metoclopramide | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55.1 Years STANDARD_DEVIATION 15.93 | 59.8 Years STANDARD_DEVIATION 16.64 | 64.3 Years STANDARD_DEVIATION 13.4 | 45.5 Years STANDARD_DEVIATION 9.68 | 57.3 Years STANDARD_DEVIATION 16.19 |
| Race/Ethnicity, Customized Race, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized Asian - South East Asian Heritage | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race, Customized White - White/Caucasian/European Heritage | 40 Participants | 42 Participants | 4 Participants | 4 Participants | 90 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 2 Participants | 1 Participants | 27 Participants |
| Sex: Female, Male Male | 28 Participants | 32 Participants | 2 Participants | 3 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 9 / 35 | 13 / 39 | 2 / 3 | 2 / 3 | 0 / 4 | 3 / 4 |
| serious Total, serious adverse events | 1 / 35 | 4 / 39 | 0 / 3 | 0 / 3 | 0 / 4 | 2 / 4 |
Outcome results
Primary
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population
The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% confidence interval (CI) were estimated and Analysis of Covariance (ANCOVA) model was used for analysis.
Time frame: Up to Day 7
Population: Intension To Treat \[ITT (exposed)\] Population. ITT (exposed) Population comprised of all randomized participants who received at least of one dose of study treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Camicinal 50 mg | Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population | 76.6 Percentage of goal volume |
| Placebo | Average Percentage Goal Volume Delivered Prior to Development of Intolerance for ITT Population | 67.7 Percentage of goal volume |
95% CI: [-5.1, 22.9]
Primary
Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population
The average percentage goal volume received via EN was defined as the percent of goal volume received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total volume received via EN during the on treatment period prior to intolerance divided by total prescribed volume. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal volume received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Time frame: Up to Day 7
Population: Per Protocol (PP) Population. PP Population comprised of all randomized participants who receive at least two doses of study treatment and have at least two days of evaluable nutritional data and also comply with the protocol.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Camicinal 50 mg | Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population | 76.6 Percentage of goal volume |
| Placebo | Average Percentage Goal Volume Delivered Prior to Development of Intolerance for PP Population | 74.4 Percentage of goal volume |
95% CI: [-6.5, 10.9]
Secondary
Average Percentage Goal Calories Delivered Prior to Development of Intolerance
The average percentage goal calories received via EN was defined as the percent of goal calories received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total calories received via EN during the on treatment period prior to intolerance divided by total prescribed calories. 'Prior to intolerance' means 'prior to start of intolerance treatment. The average percentage goal calories received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Time frame: Up to Day 7
Population: ITT (exposed) Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Camicinal 50 mg | Average Percentage Goal Calories Delivered Prior to Development of Intolerance | 76.7 Percentage of goal calories |
| Placebo | Average Percentage Goal Calories Delivered Prior to Development of Intolerance | 67.8 Percentage of goal calories |
95% CI: [-5.1, 22.9]
Secondary
Average Percentage Goal Protein Delivered Prior to Development of Intolerance
The average percentage goal protein received via EN was defined as the percent of goal protein received via EN from the first study dose up to permanent discontinuation of EN. It is calculated as 100 multiplied by total protein received via EN during the on treatment period prior to intolerance divided by total prescribed protein. 'Prior to intolerance' means 'prior to start of intolerance treatment. One participant was missing for prior to start of intolerance treatment. The average percentage goal protein received via EN was assessed and comparison between Camicinal 50mg and placebo arm was performed. Adjusted mean and its 95% CI were estimated and ANCOVA model was used for analysis.
Time frame: Up to Day 7
Population: ITT (exposed) Population
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Camicinal 50 mg | Average Percentage Goal Protein Delivered Prior to Development of Intolerance | 76.3 Percentage of goal protein |
| Placebo | Average Percentage Goal Protein Delivered Prior to Development of Intolerance | 69.8 Percentage of goal protein |
95% CI: [-6.9, 19.9]
Secondary
Change From Baseline in Albumin and Total Protein Levels
Blood samples were collected to evaluate change from Baseline in albumin and total protein values at Baseline, Day 2-7 and follow-up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 7; n= 13,11,0,0,0,0 | 0.98 Gram per liter (g/L) | Standard Deviation 6.202 |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 4; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 2; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 6; n= 0,0,1,1,1,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 7; n= 10,11,0,0,0,0 | 10.06 Gram per liter (g/L) | Standard Deviation 9.663 |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 2; n=1,1,0,0,0,0 | 4.00 Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein follow up; n= 15,16,3,3,4,2 | 16.27 Gram per liter (g/L) | Standard Deviation 13.598 |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 3; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin follow up; n= 18,17,3,3,4,2 | 5.81 Gram per liter (g/L) | Standard Deviation 5.827 |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 7; n= 0,0,1,0,2,2 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin; Day 3; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 7; n= 0,0,1,0,1,2 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 6; n= 0,0,1,1,1,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 7; n= 10,11,0,0,0,0 | 3.21 Gram per liter (g/L) | Standard Deviation 4.733 |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 6; n= 0,0,1,1,1,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 2; n=1,1,0,0,0,0 | -1.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin; Day 3; n= 0,2,0,0,0,0 | -3.50 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 4; n= 0,1,0,0,0,0 | -3.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 5; n= 0,2,0,0,0,0 | 0.50 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 6; n= 0,1,0,0,0,0 | -4.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 7; n= 13,11,0,0,0,0 | 0.64 Gram per liter (g/L) | Standard Deviation 6.795 |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 7; n= 0,0,1,0,2,2 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Albumin follow up; n= 18,17,3,3,4,2 | 4.59 Gram per liter (g/L) | Standard Deviation 6.526 |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 2; n= 0,1,0,0,0,0 | -3.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 3; n= 0,1,0,0,0,0 | 9.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 5; n= 0,2,0,0,0,0 | 7.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 6; n= 0,1,0,0,0,0 | -2.00 Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 6; n= 0,0,1,1,1,0 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 7; n= 0,0,1,0,1,2 | NA Gram per liter (g/L) | — |
| Placebo | Change From Baseline in Albumin and Total Protein Levels | Total protein follow up; n= 15,16,3,3,4,2 | 16.43 Gram per liter (g/L) | Standard Deviation 10.423 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 7; n= 10,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin; Day 3; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 6; n= 0,0,1,1,1,0 | 3.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 4; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 7; n= 0,0,1,0,2,2 | -6.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 7; n= 13,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 6; n= 0,0,1,1,1,0 | 22.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin follow up; n= 18,17,3,3,4,2 | 4.73 Gram per liter (g/L) | Standard Deviation 5.139 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 7; n= 0,0,1,0,1,2 | 4.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 2; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 3; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein follow up; n= 15,16,3,3,4,2 | 20.77 Gram per liter (g/L) | Standard Deviation 2.25 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 2; n=1,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 2; n=1,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 7; n= 0,0,1,0,1,2 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 4; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 3; n= 0,0,0,1,0,0 | 6.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 3; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 7; n= 0,0,1,0,2,2 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 2; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 4; n= 0,0,0,1,0,0 | 14.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 6; n= 0,0,1,1,1,0 | 8.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 7; n= 10,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 4; n= 0,0,0,1,0,0 | 7.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein follow up; n= 15,16,3,3,4,2 | 22.33 Gram per liter (g/L) | Standard Deviation 7.234 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 3; n= 0,0,0,1,0,0 | -3.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin; Day 3; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 6; n= 0,0,1,1,1,0 | -3.00 Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 7; n= 13,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin follow up; n= 18,17,3,3,4,2 | 8.33 Gram per liter (g/L) | Standard Deviation 3.512 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin; Day 3; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 6; n= 0,0,1,1,1,0 | 2.00 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 6; n= 0,0,1,1,1,0 | 11.00 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 7; n= 0,0,1,0,2,2 | 0.00 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 2; n=1,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein follow up; n= 15,16,3,3,4,2 | 4.50 Gram per liter (g/L) | Standard Deviation 17.54 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin follow up; n= 18,17,3,3,4,2 | 5.25 Gram per liter (g/L) | Standard Deviation 4.5 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 2; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 3; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 7; n= 0,0,1,0,1,2 | 2.00 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 7; n= 10,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 2; n= 0,0,0,0,0,1 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 4; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 7; n= 13,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein follow up; n= 15,16,3,3,4,2 | 18.60 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 7; n= 0,0,1,0,1,2 | 10.75 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin; Day 3; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 6; n= 0,0,1,1,1,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 3; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 4; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 3; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 2; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 7; n= 0,0,1,0,2,2 | 1.20 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 2; n= 0,0,0,0,0,1 | 7.00 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 5; n= 0,2,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin follow up; n= 18,17,3,3,4,2 | 2.30 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 2; n=1,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 6; n= 0,0,1,1,1,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 7; n= 13,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 7; n= 10,11,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 4; n= 0,0,0,1,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Albumin Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein intolerance Day 2; n= 0,0,0,0,0,1 | 7.00 Gram per liter (g/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Albumin and Total Protein Levels | Total protein Day 6; n= 0,1,0,0,0,0 | NA Gram per liter (g/L) | — |
Secondary
Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels
Blood samples were collected to evaluate change from Baseline in alk.phosp., ALT, AST and GGT values at Baseline, Day 1- Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 3; n= n= 0,0,2,3,3,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day7; n= 0,0,1,0,3,1 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day7; n= 0,0,1,0,2,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day5; n= 22,22,0,0,0,0 | -11.518 International Unit per liter (IU/L) | Standard Deviation 88.6693 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day6; n= 0,0,1,1,3,1 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day3; n= 0,0,2,3,2,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day7; n= 14,12,0,0,0,0 | 85.6 International Unit per liter (IU/L) | Standard Deviation 99.69 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 4; n= 0,0,2,2,3,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day5; n= 0,0,1,1,3,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 4; n= 25,25,0,0,0,0 | -4.0 International Unit per liter (IU/L) | Standard Deviation 53.27 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day4; n= 23,23,0,0,0,0 | -14.348 International Unit per liter (IU/L) | Standard Deviation 83.2317 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 4; n= 25,25,0,0,0,0 | 11.2 International Unit per liter (IU/L) | Standard Deviation 24.62 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 5; n= 0,0,2,1,3,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT follow up; n= 18,20,3,3,3,2 | 84.6 International Unit per liter (IU/L) | Standard Deviation 158.3 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALk. phosp. Day 3; n= 28,28,1,1,0,0 | -1.5 International Unit per liter (IU/L) | Standard Deviation 42.47 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day3; n= 28,29,1,1,0,0 | -11.500 International Unit per liter (IU/L) | Standard Deviation 65.8598 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day 2; n= 31,34,2,1,0,0 | -8.742 International Unit per liter (IU/L) | Standard Deviation 40.5873 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day2; n= 32,34,2,2,0,0 | 7.4 International Unit per liter (IU/L) | Standard Deviation 38.77 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day4; n= 0,0,1,2,3,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day3; n= 0,0,2,2,3,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day6; n= 18,18,0,0,0,0 | 100.1 International Unit per liter (IU/L) | Standard Deviation 150.79 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 6; n= 0,0,2,1,3,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT follow up; n= n= 18,20,3,3,4,2 | -4.6 International Unit per liter (IU/L) | Standard Deviation 93.05 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day6; n= 18,19,0,0,0,0 | 13.4 International Unit per liter (IU/L) | Standard Deviation 36.49 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 7; n= 0,0,1,0,3,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp. Day7; n= 14,13,0,0,0,0 | 13.9 International Unit per liter (IU/L) | Standard Deviation 33.93 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0 | 24.0 International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day5; n= 0,0,2,1,2,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 5; n= 22,23,0,0,0,0 | 0.4 International Unit per liter (IU/L) | Standard Deviation 70.15 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk.phosp. follow up; n= 17,20,3,2,4,2 | 32.4 International Unit per liter (IU/L) | Standard Deviation 85.8 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day2; n= 0,0,3,3,3,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 2; n= 32,35,2,2,0,0 | -1.9 International Unit per liter (IU/L) | Standard Deviation 16.07 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day1; n= 1,0,2,1,0,0 | -11.000 International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day5; n= 22,22,0,0,0,0 | 81.7 International Unit per liter (IU/L) | Standard Deviation 106.54 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day4; n= 0,0,2,2,2,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 6; n= 18,19,0,0,0,0 | 0.1 International Unit per liter (IU/L) | Standard Deviation 84.99 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day6; n= 0,0,2,1,2,2 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day7; n= 13,12,0,0,0,0 | -29.538 International Unit per liter (IU/L) | Standard Deviation 115.0454 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day4; n= 24,24,0,0,0,0 | 54.8 International Unit per liter (IU/L) | Standard Deviation 77.91 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 3; n= 29,30,1,1,0,0 | -2.8 International Unit per liter (IU/L) | Standard Deviation 37 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day3; n= 28,28,1,1,0,0 | 13.4 International Unit per liter (IU/L) | Standard Deviation 95.74 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 7; n= 14,13,0,0,0,0 | -5.4 International Unit per liter (IU/L) | Standard Deviation 95.92 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day6; n= 18,18,0,0,0,0 | -18.222 International Unit per liter (IU/L) | Standard Deviation 99.4494 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day2; n= 0,0,3,1,4,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST follow up; n= 17,20,3,2,4,2 | -33.412 International Unit per liter (IU/L) | Standard Deviation 99.3511 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day5; n= 22,23,0,0,0,0 | 14.2 International Unit per liter (IU/L) | Standard Deviation 33.14 |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 1; n= 1,0,2,3,0,0 | 1.0 International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 2; n= 0,0,3,3,4,4 | NA International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day1; n= 1,0,2,3,0,0 | 43.0 International Unit per liter (IU/L) | — |
| Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 2; n= 32,34,2,2,0,0 | 2.7 International Unit per liter (IU/L) | Standard Deviation 19.6 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day3; n= 0,0,2,3,2,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day4; n= 0,0,2,2,2,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day5; n= 0,0,2,1,2,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day6; n= 0,0,2,1,2,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day7; n= 0,0,1,0,2,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day1; n= 1,0,2,1,0,0 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALk. phosp. Day 3; n= 28,28,1,1,0,0 | 21.5 International Unit per liter (IU/L) | Standard Deviation 27.98 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day7; n= 13,12,0,0,0,0 | -11.417 International Unit per liter (IU/L) | Standard Deviation 104.7147 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 5; n= 22,23,0,0,0,0 | 6.7 International Unit per liter (IU/L) | Standard Deviation 34.8 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day5; n= 22,23,0,0,0,0 | 36.6 International Unit per liter (IU/L) | Standard Deviation 49.26 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day5; n= 22,22,0,0,0,0 | -14.318 International Unit per liter (IU/L) | Standard Deviation 66.3672 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 2; n= 0,0,3,3,4,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 4; n= 0,0,2,2,3,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 4; n= 25,25,0,0,0,0 | 25.4 International Unit per liter (IU/L) | Standard Deviation 38.55 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day 2; n= 31,34,2,1,0,0 | 0.118 International Unit per liter (IU/L) | Standard Deviation 23.3936 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day4; n= 23,23,0,0,0,0 | -14.870 International Unit per liter (IU/L) | Standard Deviation 60.7329 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day6; n= 18,18,0,0,0,0 | -10.944 International Unit per liter (IU/L) | Standard Deviation 75.4262 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day3; n= 28,29,1,1,0,0 | -4.828 International Unit per liter (IU/L) | Standard Deviation 39.626 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day2; n= 32,34,2,2,0,0 | 19.3 International Unit per liter (IU/L) | Standard Deviation 41.39 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT follow up; n= n= 18,20,3,3,4,2 | 29.2 International Unit per liter (IU/L) | Standard Deviation 62.61 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 7; n= 0,0,1,0,3,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT follow up; n= 18,20,3,3,3,2 | 84.9 International Unit per liter (IU/L) | Standard Deviation 164.37 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 6; n= 0,0,2,1,3,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day3; n= 0,0,2,2,3,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day6; n= 18,19,0,0,0,0 | 53.6 International Unit per liter (IU/L) | Standard Deviation 78.1 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 5; n= 0,0,2,1,3,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day4; n= 0,0,1,2,3,3 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day5; n= 0,0,1,1,3,2 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day6; n= 0,0,1,1,3,1 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 2; n= 32,34,2,2,0,0 | 7.9 International Unit per liter (IU/L) | Standard Deviation 19.39 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 3; n= n= 0,0,2,3,3,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day7; n= 0,0,1,0,3,1 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST follow up; n= 17,20,3,2,4,2 | 4.500 International Unit per liter (IU/L) | Standard Deviation 82.3551 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp. Day7; n= 14,13,0,0,0,0 | 74.6 International Unit per liter (IU/L) | Standard Deviation 93.12 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 7; n= 14,13,0,0,0,0 | 14.8 International Unit per liter (IU/L) | Standard Deviation 75.08 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day3; n= 28,28,1,1,0,0 | 49.8 International Unit per liter (IU/L) | Standard Deviation 62.3 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day4; n= 24,24,0,0,0,0 | 51.0 International Unit per liter (IU/L) | Standard Deviation 52.82 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 6; n= 18,19,0,0,0,0 | 8.5 International Unit per liter (IU/L) | Standard Deviation 44.37 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day5; n= 22,22,0,0,0,0 | 82.1 International Unit per liter (IU/L) | Standard Deviation 83.82 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day2; n= 0,0,3,1,4,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day6; n= 18,18,0,0,0,0 | 100.3 International Unit per liter (IU/L) | Standard Deviation 104.52 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 4; n= 25,25,0,0,0,0 | 7.0 International Unit per liter (IU/L) | Standard Deviation 29.81 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day7; n= 14,12,0,0,0,0 | 156.0 International Unit per liter (IU/L) | Standard Deviation 156.59 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 3; n= 29,30,1,1,0,0 | 7.2 International Unit per liter (IU/L) | Standard Deviation 27.49 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 2; n= 32,35,2,2,0,0 | 2.0 International Unit per liter (IU/L) | Standard Deviation 16.53 |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day2; n= 0,0,3,3,3,4 | NA International Unit per liter (IU/L) | — |
| Placebo | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk.phosp. follow up; n= 17,20,3,2,4,2 | 76.0 International Unit per liter (IU/L) | Standard Deviation 147.05 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day1; n= 1,0,2,1,0,0 | -50.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day7; n= 0,0,1,0,3,1 | -64.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 2; n= 0,0,3,3,4,4 | -25.3 International Unit per liter (IU/L) | Standard Deviation 38.37 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day7; n= 14,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day2; n= 0,0,3,3,3,4 | 51.0 International Unit per liter (IU/L) | Standard Deviation 34.18 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST follow up; n= 17,20,3,2,4,2 | -110.333 International Unit per liter (IU/L) | Standard Deviation 24.7049 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2 | 51.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp. Day7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 2; n= 32,35,2,2,0,0 | -19.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 3; n= 29,30,1,1,0,0 | 6.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3 | 47.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day3; n= 28,28,1,1,0,0 | 75.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk.phosp. follow up; n= 17,20,3,2,4,2 | 274.0 International Unit per liter (IU/L) | Standard Deviation 272.24 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day4; n= 24,24,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day2; n= 0,0,3,1,4,4 | -69.000 International Unit per liter (IU/L) | Standard Deviation 19 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day1; n= 1,0,2,3,0,0 | 66.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2 | 76.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day7; n= 13,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4 | 37.7 International Unit per liter (IU/L) | Standard Deviation 37.55 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day3; n= 0,0,2,3,2,4 | 46.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 2; n= 32,34,2,2,0,0 | 2.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 6; n= 0,0,2,1,3,2 | -75.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day6; n= 0,0,2,1,2,2 | 249.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day4; n= 0,0,2,2,2,3 | 153.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT follow up; n= n= 18,20,3,3,4,2 | -59.7 International Unit per liter (IU/L) | Standard Deviation 68.73 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0 | 38.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day3; n= 0,0,2,2,3,4 | -96.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALk. phosp. Day 3; n= 28,28,1,1,0,0 | 43.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 5; n= 0,0,2,1,3,3 | -81.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3 | 46.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day2; n= 32,34,2,2,0,0 | 5.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day4; n= 0,0,1,2,3,3 | -66.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day3; n= 28,29,1,1,0,0 | -18.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day4; n= 23,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT follow up; n= 18,20,3,3,3,2 | 140.0 International Unit per liter (IU/L) | Standard Deviation 89.87 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day5; n= 0,0,1,1,3,2 | -63.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 4; n= 0,0,2,2,3,3 | -77.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day 2; n= 31,34,2,1,0,0 | -36.500 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 7; n= 0,0,1,0,3,2 | -20.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day5; n= 0,0,2,1,2,3 | 201.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day6; n= 0,0,1,1,3,1 | -46.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4 | 22.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day7; n= 0,0,1,0,2,2 | 400.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 1; n= 1,0,2,3,0,0 | -2.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 3; n= n= 0,0,2,3,3,4 | -68.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day3; n= 28,29,1,1,0,0 | 16.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp. Day7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4 | 20.0 International Unit per liter (IU/L) | Standard Deviation 10.44 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4 | 23.0 International Unit per liter (IU/L) | Standard Deviation 17.69 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2 | 56.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 1; n= 1,0,2,3,0,0 | 9.3 International Unit per liter (IU/L) | Standard Deviation 15.5 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 7; n= 0,0,1,0,3,2 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day4; n= 0,0,1,2,3,3 | 49.500 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day6; n= 0,0,2,1,2,2 | 218.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day2; n= 0,0,3,1,4,4 | 28.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day3; n= 0,0,2,2,3,4 | 22.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day5; n= 0,0,1,1,3,2 | 46.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day6; n= 0,0,1,1,3,1 | 30.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day7; n= 0,0,1,0,3,1 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST follow up; n= 17,20,3,2,4,2 | 8.500 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day2; n= 32,34,2,2,0,0 | 8.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day3; n= 28,28,1,1,0,0 | 74.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day4; n= 24,24,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day7; n= 14,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day1; n= 1,0,2,3,0,0 | 41.7 International Unit per liter (IU/L) | Standard Deviation 52.37 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day2; n= 0,0,3,3,3,4 | 59.0 International Unit per liter (IU/L) | Standard Deviation 47.57 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day3; n= 0,0,2,3,2,4 | 89.0 International Unit per liter (IU/L) | Standard Deviation 73.08 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day4; n= 0,0,2,2,2,3 | 216.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day5; n= 0,0,2,1,2,3 | 223.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day7; n= 0,0,1,0,2,2 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT follow up; n= 18,20,3,3,3,2 | 78.0 International Unit per liter (IU/L) | Standard Deviation 29.87 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0 | 11.7 International Unit per liter (IU/L) | Standard Deviation 14.19 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3 | 56.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3 | 67.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk.phosp. follow up; n= 17,20,3,2,4,2 | 71.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 2; n= 32,35,2,2,0,0 | -1.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 3; n= 29,30,1,1,0,0 | 8.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 2; n= 0,0,3,3,4,4 | 14.0 International Unit per liter (IU/L) | Standard Deviation 7.55 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 3; n= n= 0,0,2,3,3,4 | 14.3 International Unit per liter (IU/L) | Standard Deviation 9.61 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 4; n= 0,0,2,2,3,3 | 41.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 5; n= 0,0,2,1,3,3 | 50.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 6; n= 0,0,2,1,3,2 | 45.0 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT follow up; n= n= 18,20,3,3,4,2 | 50.7 International Unit per liter (IU/L) | Standard Deviation 62.74 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day 2; n= 31,34,2,1,0,0 | -9.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day4; n= 23,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day7; n= 13,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day1; n= 1,0,2,1,0,0 | 1.000 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 2; n= 32,34,2,2,0,0 | -2.5 International Unit per liter (IU/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALk. phosp. Day 3; n= 28,28,1,1,0,0 | 19.0 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day7; n= 0,0,1,0,3,1 | -0.333 International Unit per liter (IU/L) | Standard Deviation 10.0167 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2 | 29.7 International Unit per liter (IU/L) | Standard Deviation 46.82 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day7; n= 14,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 3; n= 29,30,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day4; n= 24,24,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day3; n= 28,28,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day2; n= 32,34,2,2,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4 | 5.8 International Unit per liter (IU/L) | Standard Deviation 13.1 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 2; n= 0,0,3,3,4,4 | 6.5 International Unit per liter (IU/L) | Standard Deviation 9.47 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day6; n= 0,0,1,1,3,1 | 18.667 International Unit per liter (IU/L) | Standard Deviation 17.4738 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 3; n= n= 0,0,2,3,3,4 | 8.3 International Unit per liter (IU/L) | Standard Deviation 10.5 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day5; n= 0,0,1,1,3,2 | 19.000 International Unit per liter (IU/L) | Standard Deviation 27.0555 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp. Day7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 4; n= 0,0,2,2,3,3 | 24.3 International Unit per liter (IU/L) | Standard Deviation 30.09 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day3; n= 0,0,2,2,3,4 | 0.333 International Unit per liter (IU/L) | Standard Deviation 2.0817 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 5; n= 0,0,2,1,3,3 | 34.0 International Unit per liter (IU/L) | Standard Deviation 47.66 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day2; n= 0,0,3,1,4,4 | 8.500 International Unit per liter (IU/L) | Standard Deviation 15.1548 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT follow up; n= 18,20,3,3,3,2 | 224.0 International Unit per liter (IU/L) | Standard Deviation 24.56 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 7; n= 0,0,1,0,3,2 | 35.3 International Unit per liter (IU/L) | Standard Deviation 49.17 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day4; n= 0,0,2,2,2,3 | 45.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT follow up; n= n= 18,20,3,3,4,2 | 58.8 International Unit per liter (IU/L) | Standard Deviation 56.2 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST follow up; n= 17,20,3,2,4,2 | 47.000 International Unit per liter (IU/L) | Standard Deviation 81.5475 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALk. phosp. Day 3; n= 28,28,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day4; n= 0,0,1,2,3,3 | 22.000 International Unit per liter (IU/L) | Standard Deviation 32.187 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day1; n= 1,0,2,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day3; n= 28,29,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day4; n= 23,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day 2; n= 31,34,2,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 2; n= 32,34,2,2,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 6; n= 0,0,2,1,3,2 | 44.3 International Unit per liter (IU/L) | Standard Deviation 57.87 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 2; n= 32,35,2,2,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4 | -5.0 International Unit per liter (IU/L) | Standard Deviation 21.07 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day7; n= 0,0,1,0,2,2 | 118.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3 | 2.3 International Unit per liter (IU/L) | Standard Deviation 23.07 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day6; n= 0,0,2,1,2,2 | 116.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day5; n= 0,0,2,1,2,3 | 82.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3 | 35.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2 | 25.0 International Unit per liter (IU/L) | Standard Deviation 47.16 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day3; n= 0,0,2,3,2,4 | 28.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day2; n= 0,0,3,3,3,4 | 21.0 International Unit per liter (IU/L) | Standard Deviation 11.79 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day7; n= 13,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk.phosp. follow up; n= 17,20,3,2,4,2 | 77.5 International Unit per liter (IU/L) | Standard Deviation 86.03 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 7; n= 0,0,1,0,3,2 | 136.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day7; n= 14,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 2; n= 32,35,2,2,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day3; n= 0,0,2,3,2,4 | 65.5 International Unit per liter (IU/L) | Standard Deviation 86.38 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day5; n= 0,0,2,1,3,3 | 81.3 International Unit per liter (IU/L) | Standard Deviation 16.56 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day3; n= 28,28,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 3; n= 29,30,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day2; n= 0,0,3,3,4,4 | 18.0 International Unit per liter (IU/L) | Standard Deviation 35.13 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day4; n= 0,0,2,2,3,3 | 56.0 International Unit per liter (IU/L) | Standard Deviation 45.13 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT follow up; n= n= 18,20,3,3,4,2 | 29.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 4; n= 25,25,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day6; n= 18,18,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day4; n= 24,24,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day5; n= 0,0,2,1,2,3 | 269.3 International Unit per liter (IU/L) | Standard Deviation 60.07 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day1; n= 1,0,2,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day7; n= 13,12,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT Day2; n= 32,34,2,2,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALk. phosp. Day 3; n= 28,28,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST follow up; n= 17,20,3,2,4,2 | -3.500 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day2; n= 0,0,3,3,3,4 | 25.3 International Unit per liter (IU/L) | Standard Deviation 41.42 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day7; n= 0,0,1,0,3,1 | 171.000 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day6; n= 0,0,1,1,3,1 | 374.000 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 1; n= 1,0,2,3,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day3; n= 28,29,1,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day6; n= 0,0,2,1,3,2 | 53.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 2; n= 0,0,3,3,4,4 | 28.3 International Unit per liter (IU/L) | Standard Deviation 61.24 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day 2; n= 31,34,2,1,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp. Day7; n= 14,13,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day3; n= 0,0,2,3,3,4 | 39.3 International Unit per liter (IU/L) | Standard Deviation 38.34 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 3; n= n= 0,0,2,3,3,4 | 34.5 International Unit per liter (IU/L) | Standard Deviation 55.7 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day5; n= 0,0,1,1,3,2 | 281.000 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk.phosp. follow up; n= 17,20,3,2,4,2 | 110.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day4; n= 23,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day6; n= 0,0,2,1,2,2 | 399.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 4; n= 0,0,2,2,3,3 | 118.3 International Unit per liter (IU/L) | Standard Deviation 65.55 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day4; n= 0,0,1,2,3,3 | 126.333 International Unit per liter (IU/L) | Standard Deviation 91.1939 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day3; n= 0,0,2,2,3,4 | 20.250 International Unit per liter (IU/L) | Standard Deviation 16.8795 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. intolerance Day7; n= 0,0,1,0,3,2 | 65.5 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phsp Day6; n= 18,19,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT Day 5; n= 22,23,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 5; n= 0,0,2,1,3,3 | 193.7 International Unit per liter (IU/L) | Standard Deviation 59.58 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST intolerance Day2; n= 0,0,3,1,4,4 | 6.000 International Unit per liter (IU/L) | Standard Deviation 8.0829 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | Alk. phosp. Day 2; n= 32,34,2,2,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT follow up; n= 18,20,3,3,3,2 | 216.0 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day4; n= 0,0,2,2,2,3 | 196.7 International Unit per liter (IU/L) | Standard Deviation 129.53 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | ALT intolerance Day 6; n= 0,0,2,1,3,2 | 189.0 International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | AST Day5; n= 22,22,0,0,0,0 | NA International Unit per liter (IU/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Alkaline Phosphatase (Alk. Phosph.), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma Glutamyl Transferase (GGT) Levels | GGT intolerance Day7; n= 0,0,1,0,2,2 | 590.0 International Unit per liter (IU/L) | — |
Secondary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels
Blood samples were collected to evaluate change from Baseline in basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet and WBC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day2; n= 32,37,2,2,0,0 | -1.187 Giga unit per liter (gI/L) | Standard Deviation 3.5946 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day3; n= 2,1,0,0,0,0 | 0.6500 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day7; n= 13,15,0,0,0,0 | 0.6708 Giga unit per liter (gI/L) | Standard Deviation 7.11859 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; follow up; n= 24,28,3,3,3,1 | 0.1475 Giga unit per liter (gI/L) | Standard Deviation 0.55989 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; follow up; n= 24,28,3,3,4,2 | 258.9 Giga unit per liter (gI/L) | Standard Deviation 268.6 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day7; n= 0,0,1,0,3,2 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day6; n= 0,0,2,1,3,2 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day5; n= 0,0,2,1,3,3 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day4; n= 0,0,2,2,3,3 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day3; n= 0,0,2,3,3,4 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day2; n= 0,0,3,3,4,4 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day1; n= 1,0,2,3,0,0 | -24.0 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day7; n= 13,15,0,0,0,0 | 0.3946 Giga unit per liter (gI/L) | Standard Deviation 0.56592 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day7; n= 14,15,0,0,0,0 | 159.8 Giga unit per liter (gI/L) | Standard Deviation 229.46 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day6; n= 17,19,0,0,0,0 | 128.7 Giga unit per liter (gI/L) | Standard Deviation 168.94 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day2; n= 32,37,2,2,0,0 | 10.5 Giga unit per liter (gI/L) | Standard Deviation 40.92 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day2; n= 0,0,3,3,4,4 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day3; n= 2,1,0,0,0,0 | -5.3000 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day2; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; follow up; n= 24,28,3,3,4,1 | 1.4454 Giga unit per liter (gI/L) | Standard Deviation 6.27749 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day1; n= 1,0,2,3,0,0 | -2.020 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day7; n= 13,14,0,0,0,0 | 0.1615 Giga unit per liter (gI/L) | Standard Deviation 0.12877 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day7; n= 14,15,0,0,0,0 | 0.690 Giga unit per liter (gI/L) | Standard Deviation 8.9417 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day3; n= 2,1,0,0,0,0 | 0.3000 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day6; n= 17,19,0,0,0,0 | 0.881 Giga unit per liter (gI/L) | Standard Deviation 8.4975 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; follow up; n= 24,28,3,3,3,1 | 0.040 Giga unit per liter (gI/L) | Standard Deviation 0.0546 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; follow up; n= 24,28,3,3,4,2 | 0.6483 Giga unit per liter (gI/L) | Standard Deviation 0.51967 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day7; n= 13,14,0,0,0,0 | 0.022 Giga unit per liter (gI/L) | Standard Deviation 0.0402 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day3; n= 2,1,0,0,0,0 | 0.000 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day3; n= 2,1,0,0,0,0 | 0.5000 Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day4; n= 25,26,0,0,0,0 | -1.398 Giga unit per liter (gI/L) | Standard Deviation 6.0244 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; follow up; n= 24,28,3,3,4,2 | -1.223 Giga unit per liter (gI/L) | Standard Deviation 7.5546 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day6; n= 0,0,2,1,3,2 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day5; n= 0,0,2,1,3,3 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day7; n= 13,15,0,0,0,0 | 0.2100 Giga unit per liter (gI/L) | Standard Deviation 0.5902 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day4; n= 0,0,2,2,3,3 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day7; n= 0,0,1,0,3,2 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day3; n= 29,30,1,1,0,0 | -1.033 Giga unit per liter (gI/L) | Standard Deviation 5.8272 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day3; n= 0,0,2,3,3,4 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day5; n= 22,23,0,0,0,0 | -0.015 Giga unit per liter (gI/L) | Standard Deviation 6.5214 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day5; n= 22,23,0,0,0,0 | 102.7 Giga unit per liter (gI/L) | Standard Deviation 141 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day4; n= 25,26,0,0,0,0 | 56.0 Giga unit per liter (gI/L) | Standard Deviation 98.65 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day3; n= 29,30,1,1,0,0 | 34.8 Giga unit per liter (gI/L) | Standard Deviation 65.68 |
| Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; follow up; n= 24,28,3,3,4,2 | -2.0579 Giga unit per liter (gI/L) | Standard Deviation 6.7361 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day3; n= 29,30,1,1,0,0 | 22.1 Giga unit per liter (gI/L) | Standard Deviation 35.9 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day3; n= 2,1,0,0,0,0 | -1.0300 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day6; n= 0,1,0,0,0,0 | -0.2000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day7; n= 13,15,0,0,0,0 | 0.2320 Giga unit per liter (gI/L) | Standard Deviation 0.6689 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day6; n= 0,1,0,0,0,0 | -0.2000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; follow up; n= 24,28,3,3,3,1 | 0.0611 Giga unit per liter (gI/L) | Standard Deviation 0.39 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day3; n= 2,1,0,0,0,0 | 0.7200 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day5; n= 0,2,0,0,0,0 | -0.3750 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day6; n= 0,1,0,0,0,0 | 9.6000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day7; n= 13,15,0,0,0,0 | 1.1807 Giga unit per liter (gI/L) | Standard Deviation 3.99306 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; follow up; n= 24,28,3,3,4,2 | -2.0968 Giga unit per liter (gI/L) | Standard Deviation 3.26061 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day3; n= 0,0,2,3,3,4 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day1; n= 1,0,2,3,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day7; n= 0,0,1,0,3,2 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day4; n= 0,0,2,2,3,3 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day5; n= 0,0,2,1,3,3 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day6; n= 0,0,2,1,3,2 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; follow up; n= 24,28,3,3,4,2 | -0.813 Giga unit per liter (gI/L) | Standard Deviation 3.7488 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; follow up; n= 24,28,3,3,4,2 | 0.6614 Giga unit per liter (gI/L) | Standard Deviation 0.75393 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day2; n= 0,1,0,0,0,0 | -0.4000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day3; n= 2,1,0,0,0,0 | -0.0600 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day5; n= 0,2,0,0,0,0 | -0.0300 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day7; n= 13,15,0,0,0,0 | 0.1647 Giga unit per liter (gI/L) | Standard Deviation 0.49461 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day2; n= 0,1,0,0,0,0 | 0.000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day3; n= 2,1,0,0,0,0 | -0.020 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day5; n= 0,2,0,0,0,0 | -0.050 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day6; n= 0,1,0,0,0,0 | 0.000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day7; n= 13,14,0,0,0,0 | 0.013 Giga unit per liter (gI/L) | Standard Deviation 0.0281 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; follow up; n= 24,28,3,3,3,1 | 0.034 Giga unit per liter (gI/L) | Standard Deviation 0.0619 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day2; n= 0,1,0,0,0,0 | 0.0000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day3; n= 2,1,0,0,0,0 | -0.0400 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day5; n= 0,2,0,0,0,0 | 0.0900 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day6; n= 0,1,0,0,0,0 | -0.2000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day7; n= 13,14,0,0,0,0 | 0.1079 Giga unit per liter (gI/L) | Standard Deviation 0.22337 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; follow up; n= 24,28,3,3,4,1 | 0.1886 Giga unit per liter (gI/L) | Standard Deviation 0.27639 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day2; n= 0,1,0,0,0,0 | 0.2000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day2; n= 0,2,0,0,0,0 | -1.5000 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day2; n= 32,37,2,2,0,0 | 4.2 Giga unit per liter (gI/L) | Standard Deviation 22 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day4; n= 25,26,0,0,0,0 | 48.7 Giga unit per liter (gI/L) | Standard Deviation 55.92 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day5; n= 22,23,0,0,0,0 | 82.7 Giga unit per liter (gI/L) | Standard Deviation 75.37 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day6; n= 17,19,0,0,0,0 | 113.6 Giga unit per liter (gI/L) | Standard Deviation 95.44 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day7; n= 14,15,0,0,0,0 | 133.3 Giga unit per liter (gI/L) | Standard Deviation 99.92 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day1; n= 1,0,2,3,0,0 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day2; n= 0,0,3,3,4,4 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day4; n= 0,0,2,2,3,3 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day5; n= 0,0,2,1,3,3 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day6; n= 0,0,2,1,3,2 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day7; n= 0,0,1,0,3,2 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; follow up; n= 24,28,3,3,4,2 | 272.0 Giga unit per liter (gI/L) | Standard Deviation 226.86 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day2; n= 32,37,2,2,0,0 | -0.199 Giga unit per liter (gI/L) | Standard Deviation 2.5427 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day3; n= 29,30,1,1,0,0 | 0.398 Giga unit per liter (gI/L) | Standard Deviation 3.0461 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day4; n= 25,26,0,0,0,0 | 0.489 Giga unit per liter (gI/L) | Standard Deviation 3.7565 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day5; n= 22,23,0,0,0,0 | 1.320 Giga unit per liter (gI/L) | Standard Deviation 3.627 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day6; n= 17,19,0,0,0,0 | 2.314 Giga unit per liter (gI/L) | Standard Deviation 4.6829 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day7; n= 14,15,0,0,0,0 | 1.913 Giga unit per liter (gI/L) | Standard Deviation 3.8002 |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day2; n= 0,0,3,3,4,4 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day3; n= 0,0,2,3,3,4 | NA Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day5; n= 0,2,0,0,0,0 | 0.4400 Giga unit per liter (gI/L) | — |
| Placebo | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; follow up; n= 24,28,3,3,4,1 | 0.3367 Giga unit per liter (gI/L) | Standard Deviation 0.14844 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day7; n= 0,0,1,0,3,2 | 287.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0 | 0.1000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; follow up; n= 24,28,3,3,4,2 | 0.3133 Giga unit per liter (gI/L) | Standard Deviation 0.53529 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day3; n= 0,0,2,3,3,4 | -1.910 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day6; n= 0,0,2,1,3,2 | 0.750 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day4; n= 0,0,2,2,3,3 | 1.150 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day6; n= 0,0,1,1,0,0 | 0.000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day4; n= 0,0,2,2,3,3 | 183.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day7; n= 0,0,1,0,3,1 | 0.7900 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day7; n= 0,0,1,0,3,1 | 0.130 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day1; n= 1,0,2,3,0,0 | 33.5 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day7; n= 0,0,1,0,3,2 | 4.000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day7; n= 0,0,1,0,3,1 | -0.6900 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1 | 0.4600 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; follow up; n= 24,28,3,3,3,1 | 0.047 Giga unit per liter (gI/L) | Standard Deviation 0.0503 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day3; n= 29,30,1,1,0,0 | 0.300 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day2; n= 0,0,3,3,4,4 | -0.197 Giga unit per liter (gI/L) | Standard Deviation 2.1019 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day6; n= 0,0,1,1,1,0 | 0.9000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day6; n= 0,0,1,1,1,0 | 1.1000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day6; n= 0,0,1,1,0,0 | 0.0000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day2; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day3; n= 0,0,2,3,3,4 | 101.5 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; follow up; n= 24,28,3,3,4,2 | -0.177 Giga unit per liter (gI/L) | Standard Deviation 5.0906 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; follow up; n= 24,28,3,3,3,1 | -0.1067 Giga unit per liter (gI/L) | Standard Deviation 0.46058 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day1; n= 1,0,2,3,0,0 | 0.300 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; follow up; n= 24,28,3,3,4,2 | -0.7133 Giga unit per liter (gI/L) | Standard Deviation 5.15272 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day6; n= 0,0,2,1,3,2 | 225.5 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day2; n= 32,37,2,2,0,0 | 8.5 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day7; n= 0,0,1,0,3,1 | 1.4600 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day5; n= 0,0,2,1,3,3 | 1.850 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day5; n= 0,0,2,1,3,3 | 213.5 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day2; n= 32,37,2,2,0,0 | -2.490 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day3; n= 29,30,1,1,0,0 | -4.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; follow up; n= 24,28,3,3,4,2 | 438.0 Giga unit per liter (gI/L) | Standard Deviation 194.76 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day2; n= 0,0,3,3,4,4 | 73.7 Giga unit per liter (gI/L) | Standard Deviation 21.2 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0 | -0.3550 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day6; n= 0,0,1,1,0,0 | 0.3300 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day4; n= 0,0,2,2,3,3 | 42.5 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day3; n= 0,0,2,3,3,4 | 31.7 Giga unit per liter (gI/L) | Standard Deviation 64.79 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; follow up; n= 24,28,3,3,4,1 | 0.2267 Giga unit per liter (gI/L) | Standard Deviation 0.14189 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; follow up; n= 24,28,3,3,4,2 | 272.0 Giga unit per liter (gI/L) | Standard Deviation 27.87 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day2; n= 0,0,3,3,4,4 | 13.7 Giga unit per liter (gI/L) | Standard Deviation 73.15 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day2; n= 0,0,3,3,4,4 | -1.713 Giga unit per liter (gI/L) | Standard Deviation 3.4082 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day1; n= 1,0,2,3,0,0 | 21.0 Giga unit per liter (gI/L) | Standard Deviation 39.89 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day6; n= 0,0,1,1,1,0 | -0.8100 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day2; n= 32,37,2,2,0,0 | 14.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day4; n= 0,0,0,1,0,0 | -2.9000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day3; n= 29,30,1,1,0,0 | 10.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day4; n= 0,0,2,2,3,3 | -2.125 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day1; n= 1,0,2,3,0,0 | -1.220 Giga unit per liter (gI/L) | Standard Deviation 2.6018 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day3; n= 0,0,0,2,0,0 | -2.1000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day4; n= 0,0,0,1,0,0 | 0.1000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day3; n= 29,30,1,1,0,0 | -4.400 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day7; n= 0,0,1,0,3,2 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day6; n= 0,0,1,1,1,0 | 0.3600 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day5; n= 0,0,2,1,3,3 | -0.490 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day3; n= 0,0,0,2,0,0 | 0.000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day4; n= 0,0,0,1,0,0 | 0.000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day6; n= 0,0,2,1,3,2 | 0.300 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day6; n= 0,0,1,1,0,0 | 0.020 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day3; n= 0,0,2,3,3,4 | -1.447 Giga unit per liter (gI/L) | Standard Deviation 2.4791 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day3; n= 0,0,0,2,0,0 | 0.0900 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day7; n= 0,0,1,0,3,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; follow up; n= 24,28,3,3,3,1 | 0.057 Giga unit per liter (gI/L) | Standard Deviation 0.0379 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day7; n= 0,0,1,0,3,2 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day2; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; follow up; n= 24,28,3,3,4,2 | -0.5233 Giga unit per liter (gI/L) | Standard Deviation 1.905 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0 | 0.4800 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; follow up; n= 24,28,3,3,3,1 | -0.0633 Giga unit per liter (gI/L) | Standard Deviation 0.20502 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; follow up; n= 24,28,3,3,4,2 | 0.230 Giga unit per liter (gI/L) | Standard Deviation 2.4557 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day6; n= 0,0,2,1,3,2 | 42.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0 | -0.2000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day5; n= 0,0,2,1,3,3 | -10.0 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day3; n= 0,0,0,2,0,0 | 0.0300 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; follow up; n= 24,28,3,3,4,2 | 0.7067 Giga unit per liter (gI/L) | Standard Deviation 0.50013 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day4; n= 0,0,0,1,0,0 | 0.0000 Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day2; n= 32,37,2,2,0,0 | -2.320 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day3; n= 0,0,2,3,3,4 | -2.333 Giga unit per liter (gI/L) | Standard Deviation 5.1733 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day4; n= 0,0,2,2,3,3 | -1.300 Giga unit per liter (gI/L) | Standard Deviation 4.8446 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; follow up; n= 24,28,3,3,4,2 | 66.8 Giga unit per liter (gI/L) | Standard Deviation 272.2 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day5; n= 0,0,2,1,3,3 | -1.450 Giga unit per liter (gI/L) | Standard Deviation 8.5339 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day6; n= 0,0,2,1,3,2 | -0.367 Giga unit per liter (gI/L) | Standard Deviation 8.8047 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day7; n= 0,0,1,0,3,2 | -0.540 Giga unit per liter (gI/L) | Standard Deviation 8.7199 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; follow up; n= 24,28,3,3,4,2 | 2.188 Giga unit per liter (gI/L) | Standard Deviation 13.4717 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day2; n= 32,37,2,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day3; n= 29,30,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; follow up; n= 24,28,3,3,4,2 | 0.7100 Giga unit per liter (gI/L) | Standard Deviation 0.58395 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1 | 0.1900 Giga unit per liter (gI/L) | Standard Deviation 0.19925 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day7; n= 0,0,1,0,3,1 | 0.037 Giga unit per liter (gI/L) | Standard Deviation 0.0603 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; follow up; n= 24,28,3,3,3,1 | 0.073 Giga unit per liter (gI/L) | Standard Deviation 0.1401 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0 | 0.4000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day7; n= 0,0,1,0,3,1 | -0.0000 Giga unit per liter (gI/L) | Standard Deviation 0.19079 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; follow up; n= 24,28,3,3,4,1 | 0.0400 Giga unit per liter (gI/L) | Standard Deviation 0.81404 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day6; n= 0,0,1,1,1,0 | 7.5000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day7; n= 0,0,1,0,3,1 | -1.7200 Giga unit per liter (gI/L) | Standard Deviation 8.10489 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day3; n= 29,30,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day1; n= 1,0,2,3,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day1; n= 1,0,2,3,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day2; n= 0,0,3,3,4,4 | -1.050 Giga unit per liter (gI/L) | Standard Deviation 3.3491 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day4; n= 0,0,2,2,3,3 | 11.0 Giga unit per liter (gI/L) | Standard Deviation 67.58 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day7; n= 0,0,1,0,3,1 | 0.0600 Giga unit per liter (gI/L) | Standard Deviation 0.29866 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day6; n= 0,0,2,1,3,2 | 26.0 Giga unit per liter (gI/L) | Standard Deviation 84.55 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; follow up; n= 24,28,3,3,3,1 | -0.4900 Giga unit per liter (gI/L) | Standard Deviation 0.56427 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day2; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day6; n= 0,0,1,1,1,0 | 0.5000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day7; n= 0,0,1,0,3,2 | 49.7 Giga unit per liter (gI/L) | Standard Deviation 106.59 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; follow up; n= 24,28,3,3,4,2 | 0.8250 Giga unit per liter (gI/L) | Standard Deviation 12.6076 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day2; n= 32,37,2,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day2; n= 0,0,3,3,4,4 | -8.8 Giga unit per liter (gI/L) | Standard Deviation 24.25 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day3; n= 0,0,2,3,3,4 | 0.7 Giga unit per liter (gI/L) | Standard Deviation 46.7 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day5; n= 0,0,2,1,3,3 | 14.7 Giga unit per liter (gI/L) | Standard Deviation 75.24 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day2; n= 0,0,0,0,0,1 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day7; n= 0,0,1,0,3,1 | -6.6000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day5; n= 0,0,2,1,3,3 | -1.800 Giga unit per liter (gI/L) | Standard Deviation 5.4009 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day4; n= 0,0,2,2,3,3 | 86.3 Giga unit per liter (gI/L) | Standard Deviation 57.36 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day2; n= 0,0,3,3,4,4 | 0.450 Giga unit per liter (gI/L) | Standard Deviation 4.6177 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day2; n= 0,0,0,0,0,1 | -0.0200 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day5; n= 0,0,2,1,3,3 | 158.0 Giga unit per liter (gI/L) | Standard Deviation 99.05 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day7; n= 0,0,1,0,3,1 | 1.3000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day7; n= 0,0,1,0,3,2 | 429.0 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; follow up; n= 24,28,3,3,4,2 | -6.150 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day7; n= 0,0,1,0,3,2 | -3.650 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; follow up; n= 24,28,3,3,3,1 | 0.3600 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day3; n= 0,0,2,3,3,4 | -2.925 Giga unit per liter (gI/L) | Standard Deviation 4.9304 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day2; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance day6; n= 0,0,2,1,3,2 | 271.0 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day4; n= 0,0,2,2,3,3 | -2.933 Giga unit per liter (gI/L) | Standard Deviation 6.4733 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day7; n= 0,0,1,0,3,1 | 0.300 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day2; n= 32,37,2,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day6; n= 0,0,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day7; n= 0,0,1,0,3,1 | 1.5000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; intolerance Day2; n= 0,0,0,0,0,1 | -0.030 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day6; n= 0,0,2,1,3,2 | -5.600 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; intolerance Day7; n= 0,0,1,0,3,1 | 0.1000 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day7; n= 13,14,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day3; n= 29,30,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; follow up; n= 24,28,3,3,4,2 | -0.1200 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; follow up; n= 24,28,3,3,3,1 | 0.150 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day3; n= 29,30,1,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Basophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; follow up; n= 24,28,3,3,4,2 | 891.0 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; follow up; n= 24,28,3,3,4,1 | -0.0200 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day2; n= 0,0,0,0,0,1 | 0.0600 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day2; n= 32,37,2,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; intolerance Day1; n= 1,0,2,3,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day5; n= 22,23,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day6; n= 17,19,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day4; n= 25,26,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day7; n= 13,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; follow up; n= 24,28,3,3,4,2 | -6.7400 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day4; n= 0,0,0,1,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day6; n= 0,0,1,1,1,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | WBC; Day7; n= 14,15,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Monocytes; intolerance Day3; n= 0,0,0,2,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day1; n= 1,0,2,3,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; intolerance Day2; n= 0,0,0,0,0,1 | 0.3100 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day6; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Neutrophils; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day2; n= 0,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day2; n= 0,0,3,3,4,4 | 16.3 Giga unit per liter (gI/L) | Standard Deviation 30.1 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day5; n= 0,2,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Eosinophils; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; intolerance Day2; n= 0,0,0,0,0,1 | -0.7300 Giga unit per liter (gI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Platelet; intolerance Day3; n= 0,0,2,3,3,4 | 29.0 Giga unit per liter (gI/L) | Standard Deviation 56.94 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet and White Blood Cell (WBC) Levels | Lymphocytes; Day3; n= 2,1,0,0,0,0 | NA Giga unit per liter (gI/L) | — |
Secondary
Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values
Blood samples were collected to evaluate change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, sodium, BUN values at Baseline, up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day3; n= 0,0,2,3,3,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride follow up; n= 22,23,3,3,3,2 | -6.1 millimol per liter (mmol/L) | Standard Deviation 6.71 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day2; n= 0,0,3,3,4,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day3; n= 0,0,2,3,3,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day7; n= 0,0,1,0,2,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day2; n= 33,37,2,2,0,0 | -0.08 millimol per liter (mmol/L) | Standard Deviation 0.474 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 2; n= 32,36,2,2,0,0 | 3.31 millimol per liter (mmol/L) | Standard Deviation 10.711 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day1; n= 1,0,2,3,0,0 | 0.40 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 3; n= 0,0,2,3,2,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day7; n= 14,15,0,0,0,0 | 0.49 millimol per liter (mmol/L) | Standard Deviation 0.35 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day1; n= 1,0,2,3,0,0 | -3.0 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day6; n= 18,19,0,0,0,0 | 0.33 millimol per liter (mmol/L) | Standard Deviation 0.428 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day5; n= 22,23,0,0,0,0 | -1.4 millimol per liter (mmol/L) | Standard Deviation 4.62 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 3; n= 27,31,1,1,0,0 | 1.64 millimol per liter (mmol/L) | Standard Deviation 2.274 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day2; n= 0,0,3,3,4,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium Day5; n= 22,23,0,0,0,0 | 0.10 millimol per liter (mmol/L) | Standard Deviation 0.559 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; follow up; n= 18,22,3,3,4,1 | 2.1722 millimol per liter (mmol/L) | Standard Deviation 5.48397 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; DAY4; n= 24,25,0,0,0,0 | 0.08 millimol per liter (mmol/L) | Standard Deviation 0.705 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day2; n= 31,35,2,2,0,0 | 0.2871 millimol per liter (mmol/L) | Standard Deviation 2.68325 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day7; n= 14,15,0,0,0,0 | -2.7 millimol per liter (mmol/L) | Standard Deviation 6.4 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day5; n= 22,23,0,0,0,0 | -3.4 millimol per liter (mmol/L) | Standard Deviation 5.64 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day6; n= 18,19,0,0,0,0 | -2.8 millimol per liter (mmol/L) | Standard Deviation 6.18 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day3; n= 29,31,1,1,0,0 | -0.12 millimol per liter (mmol/L) | Standard Deviation 0.582 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; follow up; n= 15,20,3,3,3,2 | -1.26 millimol per liter (mmol/L) | Standard Deviation 6.069 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 1; n= 1,0,2,3,0,0 | -1.0 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 3; n= 1,2,0,0,0,0 | 0.0200 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day4; n= 25,26,0,0,0,0 | -0.8 millimol per liter (mmol/L) | Standard Deviation 4.03 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day6; n= 18,18,0,0,0,0 | 0.8111 millimol per liter (mmol/L) | Standard Deviation 3.37445 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; follow up; n= 18,17,3,3,4,2 | -0.8889 millimol per liter (mmol/L) | Standard Deviation 2.55225 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 7; n= 12,13,0,0,0,0 | 0.98 millimol per liter (mmol/L) | Standard Deviation 5.774 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day3; n= 1,2,0,0,0,0 | 6.4000 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day3; n= 29,31,1,1,0,0 | 0.4 millimol per liter (mmol/L) | Standard Deviation 2.47 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0 | 2.00 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day2; n= 1,3,0,0,0,0 | 1.0000 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day7; n= 13,14,0,0,0,0 | 3.1231 millimol per liter (mmol/L) | Standard Deviation 5.15948 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 6; n= 18,19,0,0,0,0 | -4.1 millimol per liter (mmol/L) | Standard Deviation 7.28 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day2; n= 33,37,2,2,0,0 | 0.3 millimol per liter (mmol/L) | Standard Deviation 2.02 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 2; n= 0,0,0,0,0,1 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 7; n= 12,12,0,0,0,0 | 0.2208 millimol per liter (mmol/L) | Standard Deviation 0.29222 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day4; n= 25,24,0,0,0,0 | 0.7680 millimol per liter (mmol/L) | Standard Deviation 2.69764 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day3; n= 0,0,2,3,3,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day2; n= 0,0,3,3,4,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; follow up; n= 25,28,3,3,4,2 | -3.8 millimol per liter (mmol/L) | Standard Deviation 4.92 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; follow up; n= 25,28,3,3,4,2 | 0.37 millimol per liter (mmol/L) | Standard Deviation 0.471 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 2; n= 0,0,3,3,4,4 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 2; n= 1,2,0,0,0,0 | -0.0500 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 6; n= 0,0,1,1,1,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day7; n= 14,13,0,0,0,0 | 1.8857 millimol per liter (mmol/L) | Standard Deviation 4.17702 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day5; n= 22,21,0,0,0,0 | 0.4636 millimol per liter (mmol/L) | Standard Deviation 2.76811 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day7; n= 14,15,0,0,0,0 | -4.3 millimol per liter (mmol/L) | Standard Deviation 7.49 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 6; n= 16,16,0,0,0,0 | 0.64 millimol per liter (mmol/L) | Standard Deviation 5.728 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; follow up; n= 19,18,3,3,4,2 | 0.2821 millimol per liter (mmol/L) | Standard Deviation 0.19277 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day6; n= 0,0,1,1,1,0 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 5; n= 20,22,0,0,0,0 | -0.16 millimol per liter (mmol/L) | Standard Deviation 3.797 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 2; n= 33,37,2,2,0,0 | -1.2 millimol per liter (mmol/L) | Standard Deviation 2.66 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day3; n= 28,31,1,1,0,0 | -1.5 millimol per liter (mmol/L) | Standard Deviation 3.38 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day1; n= 1,0,2,3,0,0 | -0.9000 millimol per liter (mmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day3; n= 29,29,1,1,0,0 | 0.2414 millimol per liter (mmol/L) | Standard Deviation 3.12667 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 4; n= 24,25,0,0,0,0 | 0.43 millimol per liter (mmol/L) | Standard Deviation 3.958 |
| Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day4 ; n= 25,26,0,0,0,0 | -2.3 millimol per liter (mmol/L) | Standard Deviation 3.93 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day6; n= 18,18,0,0,0,0 | 0.0889 millimol per liter (mmol/L) | Standard Deviation 1.7415 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day5; n= 22,23,0,0,0,0 | -2.6 millimol per liter (mmol/L) | Standard Deviation 6.93 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day3; n= 1,2,0,0,0,0 | 2.4000 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 2; n= 32,36,2,2,0,0 | 0.21 millimol per liter (mmol/L) | Standard Deviation 3.77 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride follow up; n= 22,23,3,3,3,2 | -4.6 millimol per liter (mmol/L) | Standard Deviation 6.27 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 6; n= 18,19,0,0,0,0 | -4.8 millimol per liter (mmol/L) | Standard Deviation 7.52 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day7; n= 14,15,0,0,0,0 | -3.1 millimol per liter (mmol/L) | Standard Deviation 7.14 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day4; n= 25,24,0,0,0,0 | -0.1458 millimol per liter (mmol/L) | Standard Deviation 1.96778 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day3; n= 29,29,1,1,0,0 | 0.0655 millimol per liter (mmol/L) | Standard Deviation 2.10514 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day2; n= 31,35,2,2,0,0 | -0.2338 millimol per liter (mmol/L) | Standard Deviation 1.8989 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 3; n= 0,0,2,3,2,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; follow up; n= 15,20,3,3,3,2 | -0.40 millimol per liter (mmol/L) | Standard Deviation 5.088 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day2; n= 1,3,0,0,0,0 | 2.3000 millimol per liter (mmol/L) | Standard Deviation 4.60326 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 2; n= 0,0,3,3,4,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 4; n= 0,1,0,0,0,0 | 0.0800 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; follow up; n= 18,22,3,3,4,1 | 1.7000 millimol per liter (mmol/L) | Standard Deviation 6.75891 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; follow up; n= 25,28,3,3,4,2 | -2.5 millimol per liter (mmol/L) | Standard Deviation 5.12 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day2; n= 0,0,3,3,4,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 3; n= 27,31,1,1,0,0 | 0.93 millimol per liter (mmol/L) | Standard Deviation 6.406 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day7; n= 14,15,0,0,0,0 | 0.1 millimol per liter (mmol/L) | Standard Deviation 4.24 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day6; n= 18,19,0,0,0,0 | -0.2 millimol per liter (mmol/L) | Standard Deviation 6.39 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day5; n= 22,23,0,0,0,0 | 0.8 millimol per liter (mmol/L) | Standard Deviation 5.24 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day4; n= 25,26,0,0,0,0 | 1.5 millimol per liter (mmol/L) | Standard Deviation 4.92 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day3; n= 29,31,1,1,0,0 | 1.2 millimol per liter (mmol/L) | Standard Deviation 4.2 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 7; n= 12,13,0,0,0,0 | 3.05 millimol per liter (mmol/L) | Standard Deviation 4.945 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 6; n= 0,1,0,0,0,0 | -0.0100 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day2; n= 33,37,2,2,0,0 | 0.8 millimol per liter (mmol/L) | Standard Deviation 3.34 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; follow up; n= 25,28,3,3,4,2 | 0.11 millimol per liter (mmol/L) | Standard Deviation 0.676 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day6; n= 0,0,1,1,1,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day5; n= 22,21,0,0,0,0 | 0.1810 millimol per liter (mmol/L) | Standard Deviation 2.05928 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day2; n= 0,0,3,3,4,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 3; n= 1,2,0,0,0,0 | 0.1300 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day3; n= 0,0,2,3,3,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day2; n= 0,0,3,3,4,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day3; n= 29,31,1,1,0,0 | 0.01 millimol per liter (mmol/L) | Standard Deviation 0.489 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day7; n= 14,15,0,0,0,0 | 0.05 millimol per liter (mmol/L) | Standard Deviation 0.741 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day3; n= 0,0,2,3,3,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day6; n= 18,19,0,0,0,0 | 0.09 millimol per liter (mmol/L) | Standard Deviation 0.732 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium Day5; n= 22,23,0,0,0,0 | 0.07 millimol per liter (mmol/L) | Standard Deviation 0.644 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day3; n= 0,0,2,3,3,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; DAY4; n= 24,25,0,0,0,0 | 0.06 millimol per liter (mmol/L) | Standard Deviation 0.515 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 2; n= 1,2,0,0,0,0 | 0.0000 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 5; n= 0,2,0,0,0,0 | 0.1500 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day2; n= 33,37,2,2,0,0 | 0.02 millimol per liter (mmol/L) | Standard Deviation 0.447 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; follow up; n= 18,17,3,3,4,2 | -1.7176 millimol per liter (mmol/L) | Standard Deviation 1.99663 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day7; n= 0,0,1,0,2,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day7; n= 13,14,0,0,0,0 | 5.0143 millimol per liter (mmol/L) | Standard Deviation 9.35002 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day6; n= 0,0,2,1,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 7; n= 12,12,0,0,0,0 | 0.0733 millimol per liter (mmol/L) | Standard Deviation 0.1239 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day5; n= 0,0,2,1,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; follow up; n= 19,18,3,3,4,2 | 0.2483 millimol per liter (mmol/L) | Standard Deviation 0.24957 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day4; n= 0,0,2,2,3,3 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 2; n= 0,0,0,0,0,1 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day6; n= 0,1,0,0,0,0 | 29.2000 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day4 ; n= 25,26,0,0,0,0 | -1.8 millimol per liter (mmol/L) | Standard Deviation 5.86 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day7; n= 14,13,0,0,0,0 | 0.8692 millimol per liter (mmol/L) | Standard Deviation 2.33323 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 6; n= 0,0,1,1,1,0 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day5; n= 0,2,0,0,0,0 | 25.8500 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 6; n= 16,16,0,0,0,0 | 3.63 millimol per liter (mmol/L) | Standard Deviation 5.308 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 5; n= 20,22,0,0,0,0 | 1.64 millimol per liter (mmol/L) | Standard Deviation 7.631 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 2; n= 33,37,2,2,0,0 | -0.6 millimol per liter (mmol/L) | Standard Deviation 3.38 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day3; n= 28,31,1,1,0,0 | -1.3 millimol per liter (mmol/L) | Standard Deviation 4.26 |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day4; n= 0,1,0,0,0,0 | 1.5000 millimol per liter (mmol/L) | — |
| Placebo | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 4; n= 24,25,0,0,0,0 | 1.58 millimol per liter (mmol/L) | Standard Deviation 8.054 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 7; n= 12,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 6; n= 0,0,1,1,1,0 | 0.3400 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 2; n= 0,0,3,3,4,4 | -5.3 millimol per liter (mmol/L) | Standard Deviation 3.21 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 4; n= 0,0,2,2,3,3 | -5.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 3; n= 27,31,1,1,0,0 | 6.00 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 5; n= 20,22,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0 | 3.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3 | 6.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2 | 5.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; follow up; n= 15,20,3,3,3,2 | 1.67 millimol per liter (mmol/L) | Standard Deviation 2.082 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day6; n= 18,18,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day2; n= 0,0,3,3,4,3 | -0.5000 millimol per liter (mmol/L) | Standard Deviation 2.85132 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day3; n= 0,0,2,3,3,4 | 0.5000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 2; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2 | 3.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 7; n= 12,12,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2 | 0.00 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 2; n= 0,0,0,0,0,1 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 7; n= 0,0,1,0,3,2 | -0.0700 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; follow up; n= 19,18,3,3,4,2 | 0.2667 millimol per liter (mmol/L) | Standard Deviation 0.02517 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 2; n= 33,37,2,2,0,0 | -2.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day3; n= 28,31,1,1,0,0 | -5.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day4 ; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 1; n= 1,0,2,3,0,0 | -6.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 3; n= 0,0,2,3,2,4 | -6.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day2; n= 31,35,2,2,0,0 | -0.8000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day3; n= 29,29,1,1,0,0 | -2.9000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day4; n= 25,24,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 5; n= 0,0,2,1,3,3 | -1.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 6; n= 0,0,2,1,3,2 | 0.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 7; n= 0,0,1,0,3,2 | 1.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day5; n= 22,21,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride follow up; n= 22,23,3,3,3,2 | -7.3 millimol per liter (mmol/L) | Standard Deviation 5.51 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 2; n= 32,36,2,2,0,0 | 2.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 6; n= 16,16,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day7; n= 14,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day1; n= 1,0,2,3,0,0 | -1.6000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day4; n= 0,0,2,2,3,3 | 0.8500 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day5; n= 0,0,2,1,3,3 | 0.5500 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day6; n= 0,0,2,1,3,2 | 1.1000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day7; n= 0,0,1,0,2,2 | 0.8000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; follow up; n= 18,17,3,3,4,2 | -1.9667 millimol per liter (mmol/L) | Standard Deviation 3.21921 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4 | 1.67 millimol per liter (mmol/L) | Standard Deviation 1.528 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day2; n= 33,37,2,2,0,0 | -0.20 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day3; n= 29,31,1,1,0,0 | -0.40 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2 | 6.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; DAY4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day1; n= 1,0,2,3,0,0 | 0.00 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day2; n= 0,0,3,3,4,4 | 0.00 millimol per liter (mmol/L) | Standard Deviation 0.557 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day3; n= 0,0,2,3,3,4 | -0.30 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day4; n= 0,0,2,2,3,3 | -0.15 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day5; n= 0,0,2,1,3,3 | -0.35 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day6; n= 0,0,2,1,3,2 | -0.05 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day7; n= 0,0,1,0,3,2 | -0.10 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; follow up; n= 25,28,3,3,4,2 | -0.07 millimol per liter (mmol/L) | Standard Deviation 0.379 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day2; n= 33,37,2,2,0,0 | 1.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day3; n= 29,31,1,1,0,0 | 0.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day4; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day1; n= 1,0,2,3,0,0 | -1.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day2; n= 0,0,3,3,4,4 | 0.0 millimol per liter (mmol/L) | Standard Deviation 2.65 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day3; n= 0,0,2,3,3,4 | 3.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day4; n= 0,0,2,2,3,3 | 2.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day5; n= 0,0,2,1,3,3 | 5.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day6; n= 0,0,2,1,3,2 | 4.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day7; n= 0,0,1,0,3,2 | 2.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; follow up; n= 25,28,3,3,4,2 | -3.0 millimol per liter (mmol/L) | Standard Deviation 3.46 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day2; n= 1,3,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day7; n= 13,14,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day6; n= 0,0,1,1,1,0 | 7.4000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day7; n= 0,0,1,0,3,2 | -1.0000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; follow up; n= 18,22,3,3,4,1 | -0.3333 millimol per liter (mmol/L) | Standard Deviation 3.30807 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day7; n= 14,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 7; n= 12,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 3; n= 0,0,0,1,0,0 | 0.3400 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 2; n= 0,0,0,0,0,1 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day3; n= 0,0,2,3,3,4 | 0.1000 millimol per liter (mmol/L) | Standard Deviation 1.21244 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day4; n= 0,0,2,2,3,3 | -0.3000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 7; n= 12,12,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day5; n= 0,0,2,1,3,3 | 0.2000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2 | 5.00 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day6; n= 0,0,2,1,3,2 | -0.7000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day7; n= 0,0,1,0,2,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; follow up; n= 18,17,3,3,4,2 | -0.3333 millimol per liter (mmol/L) | Standard Deviation 0.72342 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0 | 0.33 millimol per liter (mmol/L) | Standard Deviation 2.082 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 2; n= 33,37,2,2,0,0 | -0.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day2; n= 33,37,2,2,0,0 | -0.20 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3 | 1.67 millimol per liter (mmol/L) | Standard Deviation 2.309 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2 | 2.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 2; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2 | 4.00 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; DAY4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day2; n= 0,0,3,3,4,4 | 0.17 millimol per liter (mmol/L) | Standard Deviation 0.289 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day3; n= 29,31,1,1,0,0 | -0.10 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day1; n= 1,0,2,3,0,0 | 0.17 millimol per liter (mmol/L) | Standard Deviation 0.379 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day7; n= 13,14,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day3; n= 0,0,2,3,3,4 | 0.30 millimol per liter (mmol/L) | Standard Deviation 0.656 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day2; n= 0,0,3,3,4,3 | -0.3000 millimol per liter (mmol/L) | Standard Deviation 0.6245 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day1; n= 1,0,2,3,0,0 | -0.2000 millimol per liter (mmol/L) | Standard Deviation 1.3 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day4; n= 0,0,2,2,3,3 | 0.45 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day5; n= 0,0,2,1,3,3 | 0.20 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day5; n= 22,21,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 4; n= 0,0,0,1,0,0 | 0.2100 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day6; n= 0,0,2,1,3,2 | 0.40 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day4; n= 25,24,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day3; n= 29,29,1,1,0,0 | -1.6000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day3; n= 0,0,0,1,0,0 | 0.2000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; follow up; n= 25,28,3,3,4,2 | 0.47 millimol per liter (mmol/L) | Standard Deviation 0.651 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4 | 0.33 millimol per liter (mmol/L) | Standard Deviation 0.577 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day2; n= 33,37,2,2,0,0 | -0.5 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day3; n= 29,31,1,1,0,0 | -5.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 5; n= 20,22,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day4; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day4; n= 0,0,0,1,0,0 | 0.3000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 3; n= 27,31,1,1,0,0 | 3.00 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day1; n= 1,0,2,3,0,0 | -2.3 millimol per liter (mmol/L) | Standard Deviation 6.66 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 2; n= 32,36,2,2,0,0 | 1.50 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day2; n= 0,0,3,3,4,4 | -3.3 millimol per liter (mmol/L) | Standard Deviation 6.66 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride follow up; n= 22,23,3,3,3,2 | -11.0 millimol per liter (mmol/L) | Standard Deviation 5.57 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day3; n= 0,0,2,3,3,4 | -3.0 millimol per liter (mmol/L) | Standard Deviation 8.89 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; follow up; n= 18,22,3,3,4,1 | 4.5667 millimol per liter (mmol/L) | Standard Deviation 1.59478 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day4; n= 0,0,2,2,3,3 | -8.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 6; n= 0,0,2,1,3,2 | -4.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day6; n= 0,0,1,1,1,0 | 2.2000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day5; n= 0,0,2,1,3,3 | 1.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day6; n= 0,0,2,1,3,2 | -2.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 5; n= 0,0,2,1,3,3 | -2.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 4; n= 0,0,2,2,3,3 | -11.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; follow up; n= 25,28,3,3,4,2 | -7.0 millimol per liter (mmol/L) | Standard Deviation 6.08 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 3; n= 0,0,2,3,2,4 | -6.0 millimol per liter (mmol/L) | Standard Deviation 9.54 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day2; n= 1,3,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; follow up; n= 15,20,3,3,3,2 | 1.67 millimol per liter (mmol/L) | Standard Deviation 3.215 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day2; n= 31,35,2,2,0,0 | 0.3000 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 2; n= 0,0,3,3,4,4 | -4.3 millimol per liter (mmol/L) | Standard Deviation 8.5 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 1; n= 1,0,2,3,0,0 | -3.7 millimol per liter (mmol/L) | Standard Deviation 9.07 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day4 ; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day3; n= 28,31,1,1,0,0 | -7.0 millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day7; n= 0,0,1,0,3,2 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; follow up; n= 19,18,3,3,4,2 | 0.4767 millimol per liter (mmol/L) | Standard Deviation 0.22008 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 6; n= 16,16,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day6; n= 18,18,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 6; n= 0,0,1,1,1,0 | 0.3600 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4 | -2.00 millimol per liter (mmol/L) | Standard Deviation 3 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day2; n= 1,3,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day2; n= 0,0,3,3,4,4 | 0.40 millimol per liter (mmol/L) | Standard Deviation 0.258 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day3; n= 0,0,2,3,3,4 | 0.7333 millimol per liter (mmol/L) | Standard Deviation 1.90875 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day7; n= 13,14,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day3; n= 0,0,2,3,3,4 | 0.30 millimol per liter (mmol/L) | Standard Deviation 0.721 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; follow up; n= 15,20,3,3,3,2 | 1.67 millimol per liter (mmol/L) | Standard Deviation 1.528 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day4; n= 0,0,2,2,3,3 | 0.63 millimol per liter (mmol/L) | Standard Deviation 0.945 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day7; n= 14,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 6; n= 0,0,1,1,1,0 | 0.4300 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 3; n= 0,0,2,3,2,4 | 0.0 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day5; n= 0,0,2,1,3,3 | 0.67 millimol per liter (mmol/L) | Standard Deviation 0.987 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day6; n= 0,0,2,1,3,2 | 0.83 millimol per liter (mmol/L) | Standard Deviation 1.115 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day4; n= 25,24,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day2; n= 31,35,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day7; n= 0,0,1,0,3,2 | 0.87 millimol per liter (mmol/L) | Standard Deviation 1.328 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 2; n= 0,0,3,3,4,4 | 0.5 millimol per liter (mmol/L) | Standard Deviation 1 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; follow up; n= 25,28,3,3,4,2 | 0.38 millimol per liter (mmol/L) | Standard Deviation 0.443 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day3; n= 29,29,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day2; n= 33,37,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day3; n= 29,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 5; n= 20,22,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day4; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 7; n= 0,0,1,0,3,2 | 0.2000 millimol per liter (mmol/L) | Standard Deviation 0.36661 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; follow up; n= 18,22,3,3,4,1 | 11.6500 millimol per liter (mmol/L) | Standard Deviation 21.03656 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 2; n= 32,36,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 2; n= 0,0,0,0,0,1 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day2; n= 0,0,3,3,4,4 | -0.5 millimol per liter (mmol/L) | Standard Deviation 2.38 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 7; n= 12,12,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day3; n= 0,0,2,3,3,4 | 3.7 millimol per liter (mmol/L) | Standard Deviation 3.21 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 7; n= 0,0,1,0,3,2 | 4.3 millimol per liter (mmol/L) | Standard Deviation 4.04 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day4 ; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 7; n= 12,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride follow up; n= 22,23,3,3,3,2 | -7.0 millimol per liter (mmol/L) | Standard Deviation 6.08 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day2; n= 0,0,3,3,4,3 | -0.4500 millimol per liter (mmol/L) | Standard Deviation 2.496 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day4; n= 0,0,2,2,3,3 | 3.7 millimol per liter (mmol/L) | Standard Deviation 2.31 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2 | 3.00 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 6; n= 0,0,2,1,3,2 | 5.7 millimol per liter (mmol/L) | Standard Deviation 2.08 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day4; n= 0,0,2,2,3,3 | 2.1000 millimol per liter (mmol/L) | Standard Deviation 2.88444 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 2; n= 33,37,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day5; n= 22,21,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day5; n= 0,0,2,1,3,3 | 1.2333 millimol per liter (mmol/L) | Standard Deviation 3.27159 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2 | 2.00 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day5; n= 0,0,2,1,3,3 | 6.3 millimol per liter (mmol/L) | Standard Deviation 2.31 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day7; n= 0,0,1,0,3,2 | 16.4000 millimol per liter (mmol/L) | Standard Deviation 18.72004 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day6; n= 0,0,2,1,3,2 | 0.8000 millimol per liter (mmol/L) | Standard Deviation 1.7088 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 5; n= 0,0,2,1,3,3 | 4.3 millimol per liter (mmol/L) | Standard Deviation 1.53 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day7; n= 0,0,1,0,2,2 | 2.5000 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day6; n= 0,0,1,1,1,0 | 14.2000 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; follow up; n= 18,17,3,3,4,2 | -1.1750 millimol per liter (mmol/L) | Standard Deviation 2.57083 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2 | 3.00 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day6; n= 0,0,2,1,3,2 | 7.3 millimol per liter (mmol/L) | Standard Deviation 2.52 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day2; n= 33,37,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; follow up; n= 19,18,3,3,4,2 | 0.2850 millimol per liter (mmol/L) | Standard Deviation 0.39467 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3 | 1.00 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day7; n= 0,0,1,0,3,2 | 6.3 millimol per liter (mmol/L) | Standard Deviation 6.66 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2 | 2.00 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 2; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 4; n= 0,0,2,2,3,3 | 2.3 millimol per liter (mmol/L) | Standard Deviation 0.58 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 6; n= 16,16,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 3; n= 27,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; DAY4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; follow up; n= 25,28,3,3,4,2 | -0.5 millimol per liter (mmol/L) | Standard Deviation 5.45 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day3; n= 28,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day3; n= 29,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day6; n= 18,18,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day6; n= 0,0,2,1,3,2 | 0.6500 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day3; n= 28,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 4; n= 0,0,2,2,3,3 | -4.0 millimol per liter (mmol/L) | Standard Deviation 7 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day5; n= 0,0,2,1,3,3 | 0.9333 millimol per liter (mmol/L) | Standard Deviation 0.87369 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day3; n= 0,0,2,3,3,4 | 0.6000 millimol per liter (mmol/L) | Standard Deviation 1.78699 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day7; n= 0,0,1,0,2,2 | 2.65 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day2; n= 0,0,3,3,4,4 | -0.18 millimol per liter (mmol/L) | Standard Deviation 0.263 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; DAY4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 3; n= 0,0,2,3,2,4 | -2.3 millimol per liter (mmol/L) | Standard Deviation 4.99 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 2; n= 0,0,0,0,0,1 | -0.0400 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; follow up; n= 19,18,3,3,4,2 | 0.2050 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day2; n= 33,37,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day7; n= 13,14,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; follow up; n= 15,20,3,3,3,2 | 1.45 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day2; n= 0,0,3,3,4,3 | 0.8000 millimol per liter (mmol/L) | Standard Deviation 1.5 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day4; n= 0,0,2,2,3,3 | -0.10 millimol per liter (mmol/L) | Standard Deviation 1.136 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day7; n= 14,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day6; n= 0,0,1,1,1,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day4; n= 0,0,2,2,3,3 | 0.0 millimol per liter (mmol/L) | Standard Deviation 6.93 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 7; n= 12,12,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day2; n= 0,0,3,3,4,4 | 1.0 millimol per liter (mmol/L) | Standard Deviation 2.16 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day5; n= 0,0,2,1,3,3 | -0.03 millimol per liter (mmol/L) | Standard Deviation 1.115 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 2; n= 0,0,3,3,4,4 | -0.5 millimol per liter (mmol/L) | Standard Deviation 3.42 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day4; n= 25,24,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day2; n= 1,3,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day6; n= 18,18,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 2; n= 33,37,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day6; n= 0,0,2,1,3,2 | -0.55 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 3; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 4; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day2; n= 31,35,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day4; n= 0,0,2,2,3,3 | 1.1667 millimol per liter (mmol/L) | Standard Deviation 0.32146 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day7; n= 0,0,1,0,3,2 | -0.60 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride follow up; n= 22,23,3,3,3,2 | -8.5 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day6; n= 0,0,2,1,2,2 | 4.15 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 5; n= 20,22,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 7; n= 0,0,1,0,3,2 | 0.0200 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day2; n= 0,0,3,3,3,4 | 0.93 millimol per liter (mmol/L) | Standard Deviation 2.844 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day3; n= 0,0,2,3,2,3 | 2.80 millimol per liter (mmol/L) | Standard Deviation 5.071 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day3; n= 29,29,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day2; n= 33,37,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 7; n= 12,13,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 6; n= 16,16,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 2; n= 1,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day3; n= 29,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day7; n= 0,0,1,0,3,2 | -2.5 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day5; n= 0,0,2,1,3,3 | 0.0 millimol per liter (mmol/L) | Standard Deviation 6.08 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day4 ; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day4; n= 0,0,2,2,2,2 | 4.40 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day4; n= 25,26,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 4; n= 24,25,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; follow up; n= 18,22,3,3,4,1 | 2.8000 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 5; n= 0,0,2,1,3,3 | -4.7 millimol per liter (mmol/L) | Standard Deviation 4.51 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; follow up; n= 25,28,3,3,4,2 | -0.10 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day7; n= 0,0,1,0,3,2 | 1.1500 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; intolerance Day7; n= 0,0,1,0,2,2 | 0.1500 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day5; n= 0,0,2,1,2,2 | 4.75 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 3; n= 27,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day 6; n= 18,19,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; intolerance Day3; n= 0,0,2,3,3,4 | -0.53 millimol per liter (mmol/L) | Standard Deviation 1.011 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day3; n= 29,31,1,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; Day5; n= 22,21,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; Day 2; n= 32,36,2,2,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day3; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; intolerance Day4; n= 0,0,0,1,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 6; n= 0,0,2,1,3,2 | -4.0 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Glucose; follow up; n= 18,17,3,3,4,2 | 2.6000 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; Day 6; n= 0,1,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; follow up; n= 25,28,3,3,4,2 | -6.5 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Potassium; Day7; n= 14,15,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Carbon dioxide; intolerance Day1; n= 1,0,2,3,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride intolerance Day 7; n= 0,0,1,0,3,2 | -6.5 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day6; n= 0,0,2,1,3,2 | -1.0 millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Chloride; Day5; n= 22,23,0,0,0,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Calcium; intolerance Day 6; n= 0,0,1,1,1,0 | NA millimol per liter (mmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | Sodium; intolerance Day3; n= 0,0,2,3,3,4 | -0.5 millimol per liter (mmol/L) | Standard Deviation 4.65 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Calcium, Chloride, Carbon Dioxide, Glucose, Potassium, Sodium, Blood Urea Nitrogen (BUN) Values | BUN; Day5; n= 0,2,0,0,0,0 | NA millimol per liter (mmol/L) | — |
Secondary
Change From Baseline in Heart Rate (HR)
HR was measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till Day 23). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, HR was measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day6; n= 18,19,0,0,0,0 | -1.2 beats per minute (bpm) | Standard Deviation 22.26 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day6; n= 0,0,2,1,3,3 | NA beats per minute (bpm) | — |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day1; n= 1,0,3,3,3,3 | 6.0 beats per minute (bpm) | — |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day4; n= 25,27,0,0,0,0 | -4.4 beats per minute (bpm) | Standard Deviation 19.84 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day2; n= 0,0,2,3,4,4 | NA beats per minute (bpm) | — |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day5; n= 22,23,0,0,0,0 | -3.0 beats per minute (bpm) | Standard Deviation 19.21 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day1; n= 23,33,1,3,0,0 | -4.0 beats per minute (bpm) | Standard Deviation 10.05 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day7; n= 0,0,0,0,3,2 | NA beats per minute (bpm) | — |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day3; n= 0,0,2,3,3,4 | NA beats per minute (bpm) | — |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day2; n= 34,38,2,2,0,0 | -1.6 beats per minute (bpm) | Standard Deviation 15.23 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day4; n= 0,0,2,2,3,3 | NA beats per minute (bpm) | — |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR follow up; n= 27,28,3,3,4,2 | 0.8 beats per minute (bpm) | Standard Deviation 19.76 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day7; n= 14,14,,0,0,0,0 | -1.9 beats per minute (bpm) | Standard Deviation 19.17 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day3; n= 29,31, 1,1,0,0 | -0.0 beats per minute (bpm) | Standard Deviation 19.68 |
| Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day5; n= 0,0,2,1,3,3 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day4; n= 0,0,2,2,3,3 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day2; n= 0,0,2,3,4,4 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day2; n= 34,38,2,2,0,0 | -0.5 beats per minute (bpm) | Standard Deviation 14.61 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day3; n= 0,0,2,3,3,4 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day1; n= 23,33,1,3,0,0 | 4.3 beats per minute (bpm) | Standard Deviation 14.13 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day3; n= 29,31, 1,1,0,0 | 1.6 beats per minute (bpm) | Standard Deviation 12.93 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day7; n= 0,0,0,0,3,2 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day4; n= 25,27,0,0,0,0 | 2.1 beats per minute (bpm) | Standard Deviation 14.96 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day5; n= 22,23,0,0,0,0 | 0.2 beats per minute (bpm) | Standard Deviation 17.17 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day6; n= 0,0,2,1,3,3 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day6; n= 18,19,0,0,0,0 | 1.4 beats per minute (bpm) | Standard Deviation 19.46 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR follow up; n= 27,28,3,3,4,2 | 2.7 beats per minute (bpm) | Standard Deviation 25.05 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day5; n= 0,0,2,1,3,3 | NA beats per minute (bpm) | — |
| Placebo | Change From Baseline in Heart Rate (HR) | HR Day7; n= 14,14,,0,0,0,0 | 0.6 beats per minute (bpm) | Standard Deviation 22.85 |
| Placebo | Change From Baseline in Heart Rate (HR) | HR intolerance Day1; n= 1,0,3,3,3,3 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day3; n= 29,31, 1,1,0,0 | 26.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day2; n= 0,0,2,3,4,4 | 22.5 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day6; n= 18,19,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day4; n= 0,0,2,2,3,3 | 15.5 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day5; n= 0,0,2,1,3,3 | 9.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day3; n= 0,0,2,3,3,4 | 8.5 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day7; n= 0,0,0,0,3,2 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day1; n= 1,0,3,3,3,3 | 19.7 beats per minute (bpm) | Standard Deviation 8.08 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day6; n= 0,0,2,1,3,3 | 4.5 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day4; n= 25,27,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day7; n= 14,14,,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day5; n= 22,23,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR follow up; n= 27,28,3,3,4,2 | 11.0 beats per minute (bpm) | Standard Deviation 15.87 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day2; n= 34,38,2,2,0,0 | 4.5 beats per minute (bpm) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day1; n= 23,33,1,3,0,0 | -5.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day1; n= 1,0,3,3,3,3 | -2.0 beats per minute (bpm) | Standard Deviation 13.89 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day1; n= 23,33,1,3,0,0 | -0.7 beats per minute (bpm) | Standard Deviation 11.5 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day2; n= 34,38,2,2,0,0 | 5.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day3; n= 29,31, 1,1,0,0 | -21.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day4; n= 25,27,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day5; n= 22,23,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day6; n= 18,19,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day7; n= 14,14,,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day2; n= 0,0,2,3,4,4 | -12.7 beats per minute (bpm) | Standard Deviation 16.62 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day3; n= 0,0,2,3,3,4 | 0.7 beats per minute (bpm) | Standard Deviation 12.5 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day4; n= 0,0,2,2,3,3 | -2.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day5; n= 0,0,2,1,3,3 | -3.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day6; n= 0,0,2,1,3,3 | -1.0 beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day7; n= 0,0,0,0,3,2 | NA beats per minute (bpm) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR follow up; n= 27,28,3,3,4,2 | -2.0 beats per minute (bpm) | Standard Deviation 19.08 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day6; n= 18,19,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day6; n= 0,0,2,1,3,3 | 19.7 beats per minute (bpm) | Standard Deviation 22.85 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day1; n= 23,33,1,3,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day4; n= 25,27,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day5; n= 0,0,2,1,3,3 | 19.0 beats per minute (bpm) | Standard Deviation 29.87 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day3; n= 29,31, 1,1,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR follow up; n= 27,28,3,3,4,2 | 16.8 beats per minute (bpm) | Standard Deviation 21.73 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day7; n= 0,0,0,0,3,2 | 16.3 beats per minute (bpm) | Standard Deviation 20.5 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day7; n= 14,14,,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day5; n= 22,23,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day2; n= 0,0,2,3,4,4 | 9.0 beats per minute (bpm) | Standard Deviation 17.47 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day4; n= 0,0,2,2,3,3 | 14.0 beats per minute (bpm) | Standard Deviation 19.47 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR Day2; n= 34,38,2,2,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day3; n= 0,0,2,3,3,4 | 6.3 beats per minute (bpm) | Standard Deviation 11.93 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day1; n= 1,0,3,3,3,3 | 1.3 beats per minute (bpm) | Standard Deviation 13.61 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day3; n= 0,0,2,3,3,4 | 13.5 beats per minute (bpm) | Standard Deviation 12.48 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day7; n= 14,14,,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day1; n= 23,33,1,3,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day4; n= 0,0,2,2,3,3 | 5.3 beats per minute (bpm) | Standard Deviation 3.21 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day6; n= 18,19,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day5; n= 0,0,2,1,3,3 | 17.3 beats per minute (bpm) | Standard Deviation 16.17 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day5; n= 22,23,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day4; n= 25,27,0,0,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR follow up; n= 27,28,3,3,4,2 | 27.0 beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day6; n= 0,0,2,1,3,3 | 17.0 beats per minute (bpm) | Standard Deviation 11.53 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day3; n= 29,31, 1,1,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR Day2; n= 34,38,2,2,0,0 | NA beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day7; n= 0,0,0,0,3,2 | 16.0 beats per minute (bpm) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day2; n= 0,0,2,3,4,4 | 7.5 beats per minute (bpm) | Standard Deviation 11.9 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Heart Rate (HR) | HR intolerance Day1; n= 1,0,3,3,3,3 | 2.3 beats per minute (bpm) | Standard Deviation 2.52 |
Secondary
Change From Baseline in Hematocrit Level
Blood samples were collected to evaluate change from Baseline in hematocrit values at Baseline up to Day 7 and follow up (till day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day2; n= 0,0,3,3,4,4 | NA Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day3; n= 29,30,1,1,0,0 | -0.0129 Fraction of 1 | Standard Deviation 0.02555 |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day1; n= 1,0,2,3,0,0 | -0.0400 Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day5; n= 0,0,2,1,3,3 | NA Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day7; n= 0,0,1,0,3,2 | NA Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day5; n= 22,23,0,0,0,0 | -0.0085 Fraction of 1 | Standard Deviation 0.02886 |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Follow up; n= 24,28,3,3,4,2 | 0.0183 Fraction of 1 | Standard Deviation 0.05406 |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day7; n= 14,15,0,0,0,0 | -0.0148 Fraction of 1 | Standard Deviation 0.04008 |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day4; n= 0,0,2,2,3,3 | NA Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day6; n= 0,0,2,1,3,2 | NA Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day3; n= 0,0,2,3,3,4 | NA Fraction of 1 | — |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day6; n= 17,19,0,0,0,0 | -0.0152 Fraction of 1 | Standard Deviation 0.0395 |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day4; n= 25,26,0,0,0,0 | -0.0140 Fraction of 1 | Standard Deviation 0.02358 |
| Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day2; n= 32,37,2,2,0,0 | -0.0072 Fraction of 1 | Standard Deviation 0.02369 |
| Placebo | Change From Baseline in Hematocrit Level | Day4; n= 25,26,0,0,0,0 | -0.0107 Fraction of 1 | Standard Deviation 0.02226 |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day1; n= 1,0,2,3,0,0 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Day7; n= 14,15,0,0,0,0 | -0.0145 Fraction of 1 | Standard Deviation 0.03551 |
| Placebo | Change From Baseline in Hematocrit Level | Day2; n= 32,37,2,2,0,0 | -0.0048 Fraction of 1 | Standard Deviation 0.02013 |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day7; n= 0,0,1,0,3,2 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Follow up; n= 24,28,3,3,4,2 | 0.0179 Fraction of 1 | Standard Deviation 0.04098 |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day6; n= 0,0,2,1,3,2 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day2; n= 0,0,3,3,4,4 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Day3; n= 29,30,1,1,0,0 | -0.0046 Fraction of 1 | Standard Deviation 0.02342 |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day5; n= 0,0,2,1,3,3 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day4; n= 0,0,2,2,3,3 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Day5; n= 22,23,0,0,0,0 | -0.0064 Fraction of 1 | Standard Deviation 0.02956 |
| Placebo | Change From Baseline in Hematocrit Level | Intolerance Day3; n= 0,0,2,3,3,4 | NA Fraction of 1 | — |
| Placebo | Change From Baseline in Hematocrit Level | Day6; n= 17,19,0,0,0,0 | -0.0088 Fraction of 1 | Standard Deviation 0.03036 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day5; n= 0,0,2,1,3,3 | -0.0350 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day3; n= 29,30,1,1,0,0 | -0.0090 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day4; n= 25,26,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day5; n= 22,23,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day6; n= 17,19,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day7; n= 14,15,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day1; n= 1,0,2,3,0,0 | 0.0195 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day2; n= 0,0,3,3,4,4 | -0.0017 Fraction of 1 | Standard Deviation 0.02438 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Follow up; n= 24,28,3,3,4,2 | 0.0650 Fraction of 1 | Standard Deviation 0.05679 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day3; n= 0,0,2,3,3,4 | -0.0310 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day4; n= 0,0,2,2,3,3 | -0.0050 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day2; n= 32,37,2,2,0,0 | -0.0310 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day6; n= 0,0,2,1,3,2 | -0.0320 Fraction of 1 | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day7; n= 0,0,1,0,3,2 | -0.0200 Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day3; n= 29,30,1,1,0,0 | -0.0300 Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day6; n= 17,19,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day2; n= 0,0,3,3,4,4 | -0.0287 Fraction of 1 | Standard Deviation 0.02203 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day3; n= 0,0,2,3,3,4 | -0.0373 Fraction of 1 | Standard Deviation 0.02053 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day5; n= 22,23,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day2; n= 32,37,2,2,0,0 | -0.0195 Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day4; n= 0,0,2,2,3,3 | -0.0350 Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day4; n= 25,26,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Follow up; n= 24,28,3,3,4,2 | 0.0607 Fraction of 1 | Standard Deviation 0.01793 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day5; n= 0,0,2,1,3,3 | -0.0200 Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day6; n= 0,0,2,1,3,2 | -0.0200 Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day7; n= 14,15,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day7; n= 0,0,1,0,3,2 | NA Fraction of 1 | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day1; n= 1,0,2,3,0,0 | -0.0150 Fraction of 1 | Standard Deviation 0.005 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day1; n= 1,0,2,3,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day6; n= 0,0,2,1,3,2 | -0.1617 Fraction of 1 | Standard Deviation 0.30168 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day7; n= 0,0,1,0,3,2 | -0.1673 Fraction of 1 | Standard Deviation 0.31439 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day4; n= 25,26,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day2; n= 0,0,3,3,4,4 | -0.1385 Fraction of 1 | Standard Deviation 0.2679 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day5; n= 0,0,2,1,3,3 | -0.1963 Fraction of 1 | Standard Deviation 0.29767 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day4; n= 0,0,2,2,3,3 | -0.1803 Fraction of 1 | Standard Deviation 0.29416 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day7; n= 14,15,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day5; n= 22,23,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day2; n= 32,37,2,2,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day6; n= 17,19,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Intolerance Day3; n= 0,0,2,3,3,4 | -0.1917 Fraction of 1 | Standard Deviation 0.30168 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Day3; n= 29,30,1,1,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hematocrit Level | Follow up; n= 24,28,3,3,4,2 | -0.1180 Fraction of 1 | Standard Deviation 0.26962 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day2; n= 32,37,2,2,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Follow up; n= 24,28,3,3,4,2 | 0.0320 Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day4; n= 0,0,2,2,3,3 | 0.0030 Fraction of 1 | Standard Deviation 0.01836 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day7; n= 14,15,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day1; n= 1,0,2,3,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day6; n= 17,19,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day5; n= 0,0,2,1,3,3 | 0.0213 Fraction of 1 | Standard Deviation 0.01474 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day3; n= 29,30,1,1,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day6; n= 0,0,2,1,3,2 | -0.0030 Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day7; n= 0,0,1,0,3,2 | -0.0120 Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day2; n= 0,0,3,3,4,4 | -0.0113 Fraction of 1 | Standard Deviation 0.00699 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day5; n= 22,23,0,0,0,0 | NA Fraction of 1 | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Intolerance Day3; n= 0,0,2,3,3,4 | -0.0065 Fraction of 1 | Standard Deviation 0.0079 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hematocrit Level | Day4; n= 25,26,0,0,0,0 | NA Fraction of 1 | — |
Secondary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels
Blood samples were collected to evaluate change from Baseline in hemoglobin and MCHC values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up; n= 23,27,3,3,4,4 | -2.57 g/L | Standard Deviation 10.135 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day5; n= 0,0,2,1,3,3 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day3; n= 28,30,1,1,0,0 | -1.29 g/L | Standard Deviation 7.403 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day7; n= 14,15,0,0,0,0 | -4.43 g/L | Standard Deviation 13.461 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day7; n= 14,15,0,0,0,0 | -5.9 g/L | Standard Deviation 14.22 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day6; n= 17,19,0,0,0,0 | -1.94 g/L | Standard Deviation 10.413 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0 | -16.0 g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day2; n= 32,37,2,2,0,0 | -2.7 g/L | Standard Deviation 8.13 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day5; n= 22,23,0,0,0,0 | -16.50 g/L | Standard Deviation 68.162 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up; n= 24,28,3,3,4,2 | 5.1 g/L | Standard Deviation 19.13 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day3; n= 29,30,1,1,0,0 | -4.6 g/L | Standard Deviation 8.91 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day5; n= 22,23,0,0,0,0 | -3.2 g/L | Standard Deviation 10.4 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day7; n= 0,0,1,0,3,2 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day4; n= 25,26,0,0,0,0 | -4.8 g/L | Standard Deviation 7.71 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day1; n= 1,0,2,3,0,0 | 0.00 g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day2; n= 31,37,2,2,0,0 | -1.26 g/L | Standard Deviation 7.066 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day3; n= 0,0,2,3,3,4 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day4; n= 0,0,2,2,3,3 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day4; n= 25,26,0,0,0,0 | -1.24 g/L | Standard Deviation 8.232 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day6; n= 0,0,2,1,3,2 | NA g/L | — |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day6; n= 17,19,0,0,0,0 | -5.6 g/L | Standard Deviation 14.04 |
| Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day2; n= 0,0,3,3,4,4 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day6; n= 17,19,0,0,0,0 | -4.7 g/L | Standard Deviation 10.19 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day5; n= 0,0,2,1,3,3 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day7; n= 14,15,0,0,0,0 | -5.9 g/L | Standard Deviation 11.06 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day6; n= 0,0,2,1,3,2 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day7; n= 14,15,0,0,0,0 | -4.40 g/L | Standard Deviation 9.934 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day4; n= 25,26,0,0,0,0 | -5.54 g/L | Standard Deviation 8.994 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up; n= 24,28,3,3,4,2 | 4.3 g/L | Standard Deviation 13.21 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day1; n= 1,0,2,3,0,0 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day4; n= 0,0,2,2,3,3 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day2; n= 31,37,2,2,0,0 | -0.27 g/L | Standard Deviation 5.966 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day3; n= 0,0,2,3,3,4 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up; n= 23,27,3,3,4,4 | -6.33 g/L | Standard Deviation 14.475 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day7; n= 0,0,1,0,3,2 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day2; n= 0,0,3,3,4,4 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day6; n= 17,19,0,0,0,0 | -6.89 g/L | Standard Deviation 11.11 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day5; n= 22,23,0,0,0,0 | -6.39 g/L | Standard Deviation 9.852 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day2; n= 32,37,2,2,0,0 | -1.8 g/L | Standard Deviation 6.62 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day3; n= 28,30,1,1,0,0 | -2.00 g/L | Standard Deviation 7.339 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day3; n= 29,30,1,1,0,0 | -2.1 g/L | Standard Deviation 8.67 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day4; n= 25,26,0,0,0,0 | -4.7 g/L | Standard Deviation 7.59 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3 | NA g/L | — |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day5; n= 22,23,0,0,0,0 | -3.6 g/L | Standard Deviation 10.28 |
| Placebo | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day3; n= 28,30,1,1,0,0 | -13.00 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day2; n= 0,0,3,3,4,4 | -19.00 g/L | Standard Deviation 23.065 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day2; n= 32,37,2,2,0,0 | -10.5 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day1; n= 1,0,2,3,0,0 | -18.50 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day4; n= 0,0,2,2,3,3 | -12.50 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day3; n= 29,30,1,1,0,0 | -6.0 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up; n= 23,27,3,3,4,4 | -22.00 g/L | Standard Deviation 29.138 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day7; n= 0,0,1,0,3,2 | -25.00 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day6; n= 0,0,2,1,3,2 | -13.00 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0 | 2.0 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4 | -4.7 g/L | Standard Deviation 3.06 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2 | -14.0 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4 | -11.5 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day5; n= 0,0,2,1,3,3 | -6.50 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day2; n= 31,37,2,2,0,0 | -2.50 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3 | -5.0 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3 | -13.0 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day3; n= 0,0,2,3,3,4 | -6.00 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2 | -13.0 g/L | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up; n= 24,28,3,3,4,2 | 15.7 g/L | Standard Deviation 9.87 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3 | -6.0 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day3; n= 0,0,2,3,3,4 | 5.33 g/L | Standard Deviation 9.609 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day6; n= 0,0,2,1,3,2 | -10.00 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2 | -7.0 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4 | -8.7 g/L | Standard Deviation 7.57 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day2; n= 31,37,2,2,0,0 | 3.00 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day3; n= 29,30,1,1,0,0 | -7.0 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up; n= 23,27,3,3,4,4 | -5.33 g/L | Standard Deviation 9.609 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day4; n= 0,0,2,2,3,3 | 2.00 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day7; n= 0,0,1,0,3,2 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day2; n= 0,0,3,3,4,4 | 1.67 g/L | Standard Deviation 12.702 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day5; n= 0,0,2,1,3,3 | -5.00 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up; n= 24,28,3,3,4,2 | 19.0 g/L | Standard Deviation 8.19 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4 | -11.0 g/L | Standard Deviation 4.58 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0 | -4.0 g/L | Standard Deviation 1.73 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day3; n= 28,30,1,1,0,0 | 6.00 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day1; n= 1,0,2,3,0,0 | 1.00 g/L | Standard Deviation 8.544 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day2; n= 32,37,2,2,0,0 | -4.5 g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3 | -10.0 g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day3; n= 29,30,1,1,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3 | -7.0 g/L | Standard Deviation 10 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day2; n= 0,0,3,3,4,4 | -0.50 g/L | Standard Deviation 4.655 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day4; n= 0,0,2,2,3,3 | -4.00 g/L | Standard Deviation 6.557 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day6; n= 0,0,2,1,3,2 | -8.00 g/L | Standard Deviation 18.248 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day7; n= 0,0,1,0,3,2 | -8.67 g/L | Standard Deviation 15.535 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up; n= 23,27,3,3,4,4 | -11.75 g/L | Standard Deviation 11.026 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day2; n= 32,37,2,2,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4 | 0.5 g/L | Standard Deviation 4.2 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4 | -2.7 g/L | Standard Deviation 7.09 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3 | -0.7 g/L | Standard Deviation 8.74 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2 | 5.7 g/L | Standard Deviation 10.02 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2 | 2.7 g/L | Standard Deviation 9.24 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up; n= 24,28,3,3,4,2 | 3.5 g/L | Standard Deviation 8.81 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day2; n= 31,37,2,2,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day3; n= 28,30,1,1,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day1; n= 1,0,2,3,0,0 | NA g/L | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day3; n= 0,0,2,3,3,4 | -2.67 g/L | Standard Deviation 9.815 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day5; n= 0,0,2,1,3,3 | -10.00 g/L | Standard Deviation 12.288 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day1; n= 1,0,2,3,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day3; n= 28,30,1,1,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day2; n= 31,37,2,2,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; follow up; n= 24,28,3,3,4,2 | 2.5 g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day7; n= 0,0,1,0,3,2 | -5.5 g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day6; n= 0,0,2,1,3,2 | -5.5 g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day5; n= 0,0,2,1,3,3 | 4.3 g/L | Standard Deviation 1.53 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day5; n= 22,23,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day4; n= 0,0,2,2,3,3 | -11.67 g/L | Standard Deviation 18.23 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day4; n= 0,0,2,2,3,3 | -1.7 g/L | Standard Deviation 5.69 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day3; n= 0,0,2,3,3,4 | -3.8 g/L | Standard Deviation 4.27 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day2; n= 0,0,3,3,3,4 | -4.5 g/L | Standard Deviation 2.52 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; follow up; n= 23,27,3,3,4,4 | -25.00 g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day5; n= 0,0,2,1,3,3 | -11.67 g/L | Standard Deviation 23.352 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Intolerance Day1; n= 1,0,2,3,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day4; n= 25,26,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day6; n= 0,0,2,1,3,2 | -23.50 g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day3; n= 29,30,1,1,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | Hemoglobin; Day2; n= 32,37,2,2,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day3; n= 0,0,2,3,3,4 | -3.75 g/L | Standard Deviation 11.325 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day7; n= 0,0,1,0,3,2 | -8.50 g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day7; n= 14,15,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; Day6; n= 17,19,0,0,0,0 | NA g/L | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) Levels | MCHC; intolerance Day2; n= 0,0,3,3,4,4 | -3.00 g/L | Standard Deviation 6.831 |
Secondary
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels
Blood samples were collected to evaluate change from Baseline in MCH values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day4; n= 0,0,2,1,2,2 | NA Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day7; n= 0,0,1,0,2,1 | NA Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day4; n= 21,24,0,0,0,0 | -0.26 Picogram (PG) | Standard Deviation 0.685 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day7; n= 12,14,0,0,0,0 | -0.02 Picogram (PG) | Standard Deviation 0.488 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day6; n= 0,0,2,1,2,1 | NA Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up; n= 21,26,3,2,3,2 | -0.40 Picogram (PG) | Standard Deviation 0.889 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day5; n= 19,21,0,0,0,0 | -0.23 Picogram (PG) | Standard Deviation 0.628 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day3; n= 0,0,2,2,2,3 | NA Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day2; n= 0,0,3,2,3,3 | NA Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day2; n= 27,35,2,1,0,0 | 0.01 Picogram (PG) | Standard Deviation 0.522 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day1; n= 1,0,2,2,0,0 | 0.20 Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day3; n= 24,28,1,0,0,0 | -0.10 Picogram (PG) | Standard Deviation 0.581 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day5; n= 0,0,2,1,2,2 | NA Picogram (PG) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day6; n= 15,17,0,0,0,0 | -0.15 Picogram (PG) | Standard Deviation 0.505 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day5; n= 0,0,2,1,2,2 | NA Picogram (PG) | — |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day2; n= 0,0,3,2,3,3 | NA Picogram (PG) | — |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day3; n= 0,0,2,2,2,3 | NA Picogram (PG) | — |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day7; n= 0,0,1,0,2,1 | NA Picogram (PG) | — |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day3; n= 24,28,1,0,0,0 | -0.08 Picogram (PG) | Standard Deviation 0.547 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up; n= 21,26,3,2,3,2 | -0.20 Picogram (PG) | Standard Deviation 0.944 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day4; n= 21,24,0,0,0,0 | -0.24 Picogram (PG) | Standard Deviation 0.69 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day6; n= 0,0,2,1,2,1 | NA Picogram (PG) | — |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day5; n= 19,21,0,0,0,0 | -0.44 Picogram (PG) | Standard Deviation 0.494 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day6; n= 15,17,0,0,0,0 | -0.41 Picogram (PG) | Standard Deviation 0.431 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day4; n= 0,0,2,1,2,2 | NA Picogram (PG) | — |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day7; n= 12,14,0,0,0,0 | -0.45 Picogram (PG) | Standard Deviation 0.435 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day2; n= 27,35,2,1,0,0 | 0.02 Picogram (PG) | Standard Deviation 0.531 |
| Placebo | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day1; n= 1,0,2,2,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day6; n= 15,17,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day7; n= 0,0,1,0,2,1 | -0.50 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day5; n= 0,0,2,1,2,2 | 0.45 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day4; n= 0,0,2,1,2,2 | -0.10 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day3; n= 0,0,2,2,2,3 | -0.10 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day1; n= 1,0,2,2,0,0 | -0.65 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day7; n= 12,14,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day2; n= 27,35,2,1,0,0 | 0.35 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day6; n= 0,0,2,1,2,1 | 0.20 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up; n= 21,26,3,2,3,2 | -0.50 Picogram (PG) | Standard Deviation 1.652 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day5; n= 19,21,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day4; n= 21,24,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day3; n= 24,28,1,0,0,0 | 0.20 Picogram (PG) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day2; n= 0,0,3,2,3,3 | -0.57 Picogram (PG) | Standard Deviation 1.06 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day3; n= 0,0,2,2,2,3 | -0.10 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day5; n= 19,21,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day2; n= 27,35,2,1,0,0 | 0.00 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day3; n= 24,28,1,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day4; n= 21,24,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day6; n= 15,17,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day7; n= 12,14,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day1; n= 1,0,2,2,0,0 | -0.30 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day2; n= 0,0,3,2,3,3 | -0.10 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day4; n= 0,0,2,1,2,2 | -0.60 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day5; n= 0,0,2,1,2,2 | -0.50 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day6; n= 0,0,2,1,2,1 | -1.10 Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day7; n= 0,0,1,0,2,1 | NA Picogram (PG) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up; n= 21,26,3,2,3,2 | -2.15 Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day6; n= 15,17,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day6; n= 0,0,2,1,2,1 | -1.00 Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day5; n= 19,21,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day5; n= 0,0,2,1,2,2 | -1.00 Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day1; n= 1,0,2,2,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day2; n= 27,35,2,1,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up; n= 21,26,3,2,3,2 | -0.50 Picogram (PG) | Standard Deviation 0.8 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day7; n= 0,0,1,0,2,1 | -0.75 Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day7; n= 12,14,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day4; n= 0,0,2,1,2,2 | -0.75 Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day3; n= 24,28,1,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day3; n= 0,0,2,2,2,3 | -0.65 Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day4; n= 21,24,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day2; n= 0,0,3,2,3,3 | -0.23 Picogram (PG) | Standard Deviation 0.681 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Follow up; n= 21,26,3,2,3,2 | -0.90 Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day7; n= 12,14,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day4; n= 0,0,2,1,2,2 | -0.50 Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day6; n= 15,17,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day5; n= 0,0,2,1,2,2 | -0.30 Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day5; n= 19,21,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day4; n= 21,24,0,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day1; n= 1,0,2,2,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day6; n= 0,0,2,1,2,1 | -0.70 Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day3; n= 24,28,1,0,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Day2; n= 27,35,2,1,0,0 | NA Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day7; n= 0,0,1,0,2,1 | 0.40 Picogram (PG) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day2; n= 0,0,3,2,3,3 | -0.10 Picogram (PG) | Standard Deviation 0.265 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Levels | Intolerance Day3; n= 0,0,2,2,2,3 | -0.27 Picogram (PG) | Standard Deviation 0.153 |
Secondary
Change From Baseline in Mean Corpuscle Volume (MCV) Levels
Blood samples were collected to evaluate change from Baseline in MCV values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day6; n= 0,0,2,1,3,2 | NA Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day6; n= 17,19,0,0,0,0 | 0.17 Femtoliter (fL) | Standard Deviation 3.098 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day5; n= 22,23,0,0,0,0 | 0.09 Femtoliter (fL) | Standard Deviation 2.661 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day4; n= 25,26,0,0,0,0 | -0.14 Femtoliter (fL) | Standard Deviation 2.108 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day7; n= 0,01,0,3,2 | NA Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day4; n= 0,0,2,2,3,3 | NA Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day3; n= 0,0,2,3,3,4 | NA Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day2; n= 0,0,3,3,4,4 | NA Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Follow up; n= 23,27,3,3,4,2 | -0.24 Femtoliter (fL) | Standard Deviation 3.394 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day5; n= 0,0,2,1,3,3 | NA Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day1; n= 1,0,2,3,0,0 | 0.50 Femtoliter (fL) | — |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day7; n= 14,15,0,0,0,0 | 1.04 Femtoliter (fL) | Standard Deviation 3.68 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day3; n= 28,30,1,1,0,0 | 0.13 Femtoliter (fL) | Standard Deviation 1.431 |
| Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day2; n= 31,37,2,2,0,0 | 0.36 Femtoliter (fL) | Standard Deviation 1.349 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day6; n= 0,0,2,1,3,2 | NA Femtoliter (fL) | — |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day7; n= 0,01,0,3,2 | NA Femtoliter (fL) | — |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Follow up; n= 23,27,3,3,4,2 | 1.46 Femtoliter (fL) | Standard Deviation 4.28 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day2; n= 31,37,2,2,0,0 | 0.14 Femtoliter (fL) | Standard Deviation 1.478 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day3; n= 28,30,1,1,0,0 | 0.40 Femtoliter (fL) | Standard Deviation 1.627 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day4; n= 25,26,0,0,0,0 | 0.79 Femtoliter (fL) | Standard Deviation 2.017 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day5; n= 22,23,0,0,0,0 | 0.40 Femtoliter (fL) | Standard Deviation 2.042 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day6; n= 17,19,0,0,0,0 | 0.53 Femtoliter (fL) | Standard Deviation 2.515 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day7; n= 14,15,0,0,0,0 | -0.01 Femtoliter (fL) | Standard Deviation 2.669 |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day1; n= 1,0,2,3,0,0 | NA Femtoliter (fL) | — |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day2; n= 0,0,3,3,4,4 | NA Femtoliter (fL) | — |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day3; n= 0,0,2,3,3,4 | NA Femtoliter (fL) | — |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day4; n= 0,0,2,2,3,3 | NA Femtoliter (fL) | — |
| Placebo | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day5; n= 0,0,2,1,3,3 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Follow up; n= 23,27,3,3,4,2 | 4.57 Femtoliter (fL) | Standard Deviation 3.774 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day6; n= 0,0,2,1,3,2 | 3.95 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day1; n= 1,0,2,3,0,0 | 3.10 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day6; n= 17,19,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day2; n= 0,0,3,3,4,4 | 3.43 Femtoliter (fL) | Standard Deviation 3.182 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day7; n= 0,01,0,3,2 | 5.10 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day4; n= 25,26,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day4; n= 0,0,2,2,3,3 | 3.05 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day5; n= 22,23,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day3; n= 0,0,2,3,3,4 | 1.30 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day7; n= 14,15,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day2; n= 31,37,2,2,0,0 | 1.70 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day3; n= 28,30,1,1,0,0 | 3.90 Femtoliter (fL) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day5; n= 0,0,2,1,3,3 | 2.90 Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day2; n= 31,37,2,2,0,0 | -0.50 Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day5; n= 22,23,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Follow up; n= 23,27,3,3,4,2 | -2.93 Femtoliter (fL) | Standard Deviation 0.902 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day7; n= 14,15,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day6; n= 17,19,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day1; n= 1,0,2,3,0,0 | -1.10 Femtoliter (fL) | Standard Deviation 0.854 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day2; n= 0,0,3,3,4,4 | 0.00 Femtoliter (fL) | Standard Deviation 1.732 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day5; n= 0,0,2,1,3,3 | 0.10 Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day3; n= 0,0,2,3,3,4 | -1.20 Femtoliter (fL) | Standard Deviation 1.709 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day7; n= 0,01,0,3,2 | NA Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day6; n= 0,0,2,1,3,2 | -0.20 Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day3; n= 28,30,1,1,0,0 | 0.00 Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day4; n= 0,0,2,2,3,3 | -1.10 Femtoliter (fL) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day4; n= 25,26,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day5; n= 22,23,0,0,0,0 | -1.10 Femtoliter (fL) | Standard Deviation 3.804 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day3; n= 0,0,2,3,3,4 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day6; n= 17,19,0,0,0,0 | -2.20 Femtoliter (fL) | Standard Deviation 5.8 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day4; n= 0,0,2,2,3,3 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Follow up; n= 23,27,3,3,4,2 | -0.77 Femtoliter (fL) | Standard Deviation 5.557 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day3; n= 28,30,1,1,0,0 | -2.47 Femtoliter (fL) | Standard Deviation 3.101 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day2; n= 0,0,3,3,4,4 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day5; n= 0,0,2,1,3,3 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day1; n= 1,0,2,3,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day4; n= 25,26,0,0,0,0 | -2.53 Femtoliter (fL) | Standard Deviation 2.194 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day7; n= 14,15,0,0,0,0 | -1.13 Femtoliter (fL) | Standard Deviation 5.244 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day7; n= 0,01,0,3,2 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day2; n= 31,37,2,2,0,0 | -0.60 Femtoliter (fL) | Standard Deviation 0.876 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day6; n= 0,0,2,1,3,2 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Follow up; n= 23,27,3,3,4,2 | 4.00 Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day5; n= 22,23,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day3; n= 0,0,2,3,3,4 | 0.27 Femtoliter (fL) | Standard Deviation 2.968 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day3; n= 28,30,1,1,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day4; n= 25,26,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day6; n= 17,19,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day7; n= 14,15,0,0,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day1; n= 1,0,2,3,0,0 | NA Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day2; n= 0,0,3,3,4,4 | 0.92 Femtoliter (fL) | Standard Deviation 1.187 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day4; n= 0,0,2,2,3,3 | 2.30 Femtoliter (fL) | Standard Deviation 4.107 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day5; n= 0,0,2,1,3,3 | 3.13 Femtoliter (fL) | Standard Deviation 5.169 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day6; n= 0,0,2,1,3,2 | 5.60 Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Intolerance Day7; n= 0,01,0,3,2 | 4.15 Femtoliter (fL) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Mean Corpuscle Volume (MCV) Levels | Day2; n= 31,37,2,2,0,0 | NA Femtoliter (fL) | — |
Secondary
Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count
Blood samples were collected to evaluate change from Baseline in RBC and reticulocytes values at Baseline up to Day 7 and follow up (till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day5; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day1; n= 1,0,2,3,0,0 | -0.540 Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day2; n= 0,0,3,3,4,4 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day5; n= 0,0,2,1,3,3 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day4; n= 0,0,2,2,3,3 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day2; n= 32,37,2,2,0,0 | -0.098 Tetra unit per liter (TI/L) | Standard Deviation 0.2816 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day3; n= 0,0,2,3,3,4 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day3; n= 29,30,1,1,0,0 | -0.163 Tetra unit per liter (TI/L) | Standard Deviation 0.3001 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day7; n= 0,0,1,0,3,2 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day6; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day4; n= 25,26,0,0,0,0 | -0.155 Tetra unit per liter (TI/L) | Standard Deviation 0.3038 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day6; n= 0,0,2,1,3,2 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day5; n= 22,23,0,0,0,0 | -0.099 Tetra unit per liter (TI/L) | Standard Deviation 0.3676 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC follow up; n= 24,28,3,3,4,2 | 0.195 Tetra unit per liter (TI/L) | Standard Deviation 0.6553 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1 | NA Tetra unit per liter (TI/L) | — |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day6; n= 17,19,0,0,0,0 | -0.176 Tetra unit per liter (TI/L) | Standard Deviation 0.4999 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; follow up; n= 11,11,2,2,3,2 | 4.1273 Tetra unit per liter (TI/L) | Standard Deviation 13.55607 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day7; n= 14,15,0,0,0,0 | -0.202 Tetra unit per liter (TI/L) | Standard Deviation 0.4849 |
| Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day7; n= 7,4,0,0,0,0 | 0.0074 Tetra unit per liter (TI/L) | Standard Deviation 0.04599 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day2; n= 32,37,2,2,0,0 | -0.059 Tetra unit per liter (TI/L) | Standard Deviation 0.2262 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day1; n= 1,0,2,3,0,0 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day7; n= 7,4,0,0,0,0 | 0.0031 Tetra unit per liter (TI/L) | Standard Deviation 0.01158 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day4; n= 0,0,2,2,3,3 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day4; n= 25,26,0,0,0,0 | -0.141 Tetra unit per liter (TI/L) | Standard Deviation 0.2417 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day6; n= 0,1,0,0,0,0 | 0.0810 Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day2; n= 0,0,3,3,4,4 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day6; n= 0,0,2,1,3,2 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day6; n= 17,19,0,0,0,0 | -0.118 Tetra unit per liter (TI/L) | Standard Deviation 0.3403 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC follow up; n= 24,28,3,3,4,2 | 0.142 Tetra unit per liter (TI/L) | Standard Deviation 0.4196 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day3; n= 0,0,2,3,3,4 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day7; n= 14,15,0,0,0,0 | -0.149 Tetra unit per liter (TI/L) | Standard Deviation 0.361 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day7; n= 0,0,1,0,3,2 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day5; n= 22,23,0,0,0,0 | -0.085 Tetra unit per liter (TI/L) | Standard Deviation 0.3246 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day5; n= 0,0,2,1,3,3 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day3; n= 29,30,1,1,0,0 | -0.067 Tetra unit per liter (TI/L) | Standard Deviation 0.2776 |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day5; n= 0,1,0,0,0,0 | -0.0010 Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Placebo | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; follow up; n= 11,11,2,2,3,2 | 1.6622 Tetra unit per liter (TI/L) | Standard Deviation 5.41884 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day4; n= 0,0,2,2,3,3 | -0.165 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day5; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day6; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day7; n= 7,4,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day3; n= 29,30,1,1,0,0 | -0.210 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; follow up; n= 11,11,2,2,3,2 | 0.0847 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day4; n= 25,26,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1 | 0.0170 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day5; n= 22,23,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day6; n= 17,19,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day7; n= 14,15,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day1; n= 1,0,2,3,0,0 | 0.120 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day2; n= 0,0,3,3,4,4 | -0.113 Tetra unit per liter (TI/L) | Standard Deviation 0.1701 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day3; n= 0,0,2,3,3,4 | -0.390 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day5; n= 0,0,2,1,3,3 | -0.495 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day6; n= 0,0,2,1,3,2 | -0.505 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day2; n= 32,37,2,2,0,0 | -0.375 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day7; n= 0,0,1,0,3,2 | -0.400 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC follow up; n= 24,28,3,3,4,2 | 0.577 Tetra unit per liter (TI/L) | Standard Deviation 0.4826 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day4; n= 0,0,2,2,3,3 | -0.270 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day6; n= 17,19,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day5; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day5; n= 0,0,2,1,3,3 | -0.150 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day5; n= 22,23,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; follow up; n= 11,11,2,2,3,2 | 0.0537 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day4; n= 25,26,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0 | 0.0530 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day6; n= 0,0,2,1,3,2 | -0.130 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC follow up; n= 24,28,3,3,4,2 | 0.790 Tetra unit per liter (TI/L) | Standard Deviation 0.1493 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day3; n= 29,30,1,1,0,0 | -0.200 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day7; n= 7,4,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day2; n= 32,37,2,2,0,0 | -0.150 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0 | 0.0080 Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day7; n= 0,0,1,0,3,2 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day3; n= 0,0,2,3,3,4 | -0.333 Tetra unit per liter (TI/L) | Standard Deviation 0.1563 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day6; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day2; n= 0,0,3,3,4,4 | -0.293 Tetra unit per liter (TI/L) | Standard Deviation 0.2335 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day1; n= 1,0,2,3,0,0 | -0.077 Tetra unit per liter (TI/L) | Standard Deviation 0.0586 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day7; n= 14,15,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day1; n= 1,0,2,3,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day3; n= 0,0,2,3,3,4 | -0.030 Tetra unit per liter (TI/L) | Standard Deviation 0.2042 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day5; n= 0,0,2,1,3,3 | -0.157 Tetra unit per liter (TI/L) | Standard Deviation 0.3371 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day7; n= 0,0,1,0,3,2 | 0.150 Tetra unit per liter (TI/L) | Standard Deviation 0.2598 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day7; n= 7,4,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day2; n= 32,37,2,2,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day3; n= 29,30,1,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day4; n= 25,26,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day5; n= 22,23,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day6; n= 17,19,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day7; n= 14,15,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day2; n= 0,0,3,3,4,4 | 0.018 Tetra unit per liter (TI/L) | Standard Deviation 0.1228 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day4; n= 0,0,2,2,3,3 | 0.047 Tetra unit per liter (TI/L) | Standard Deviation 0.3075 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day6; n= 0,0,2,1,3,2 | 0.267 Tetra unit per liter (TI/L) | Standard Deviation 0.3055 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC follow up; n= 24,28,3,3,4,2 | 0.188 Tetra unit per liter (TI/L) | Standard Deviation 0.3636 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day5; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day6; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0 | 0.0340 Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; follow up; n= 11,11,2,2,3,2 | 0.0870 Tetra unit per liter (TI/L) | Standard Deviation 0.02364 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day6; n= 0,0,2,1,3,2 | -0.170 Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day5; n= 0,0,2,1,3,3 | 0.133 Tetra unit per liter (TI/L) | Standard Deviation 0.0306 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day3; n= 0,0,2,3,3,4 | -0.105 Tetra unit per liter (TI/L) | Standard Deviation 0.1511 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day2; n= 0,0,3,3,4,4 | -0.172 Tetra unit per liter (TI/L) | Standard Deviation 0.1159 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day7; n= 0,0,1,0,3,2 | -0.250 Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day4; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day1; n= 1,0,2,3,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day7; n= 14,15,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day6; n= 17,19,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; intolerance Day4; n= 0,0,2,2,3,3 | -0.050 Tetra unit per liter (TI/L) | Standard Deviation 0.239 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day6; n= 0,0,0,0,1,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day5; n= 22,23,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day4; n= 25,26,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day3; n= 29,30,1,1,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; follow up; n= 11,11,2,2,3,2 | 0.0569 Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day7; n= 0,0,1,0,0,1 | 0.0822 Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC; Day2; n= 32,37,2,2,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day7; n= 7,4,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day6; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; Day5; n= 0,1,0,0,0,0 | NA Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | RBC follow up; n= 24,28,3,3,4,2 | 0.170 Tetra unit per liter (TI/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Red Blood Cell (RBC) and Reticulocyte Count | Reticulocytes; intolerance Day3; n= 0,0,0,1,0,0 | NA Tetra unit per liter (TI/L) | — |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP and DBP were measured at Baseline, Day 1, up to 6 hrs pre-dose on Day 2-7 and at follow-up (till 23 days). The Baseline value was considered to be the participant's last available assessment prior to randomized treatment. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, SBP and DBP were measured at Day 1 to Day 7 post-intolerance. NA indicates that data were not available. Only those participants with data available at the specified data points were analyzed (represented by n=X in the category titles). If n \< 3 the standard deviation (SD) was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day1; n= 23,33,1,3,0,0 | -4.6 millimeter of mercury (mmHg) | Standard Deviation 19.58 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Follow up; n= 27,28,3,3,4,2 | 9.1 millimeter of mercury (mmHg) | Standard Deviation 20.14 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day5; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day6; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day6; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day3; n= 29,31,1,1,0,0 | 2.2 millimeter of mercury (mmHg) | Standard Deviation 12.12 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day5; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day4; n=25,27,0,0,0,0 | 2.9 millimeter of mercury (mmHg) | Standard Deviation 15.03 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP follow up; n= 27,28,3,3,4,2 | -0.6 millimeter of mercury (mmHg) | Standard Deviation 25.75 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day4; n= 0,0,2,2,3,3 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day3; n= 0,0,2,3,3,4 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day5; n= 22,23,0,0,0,0 | 5.3 millimeter of mercury (mmHg) | Standard Deviation 16.12 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day2; n= 0,0,2,3,4,4 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day6; n= 18,19,0,0,0,0 | 2.6 millimeter of mercury (mmHg) | Standard Deviation 17.03 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day2; n= 33,38,2,2,0,0 | 2.7 millimeter of mercury (mmHg) | Standard Deviation 12.77 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day1; n= 1,0,3,3,3,3 | -2.0 millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day7; n= 14,14,0,0,0,0 | -2.5 millimeter of mercury (mmHg) | Standard Deviation 37.96 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day7; n= 14,14,0,0,0,0 | -4.6 millimeter of mercury (mmHg) | Standard Deviation 15.33 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day6; n= 18,19,0,0,0,0 | -1.6 millimeter of mercury (mmHg) | Standard Deviation 34.29 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day1; n=1,0,3,3,3,3 | 7.0 millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day1; n= 23,33,1,3,0,0 | -1.1 millimeter of mercury (mmHg) | Standard Deviation 10.51 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day5; n= 22,23,0,0,0,0 | 11.3 millimeter of mercury (mmHg) | Standard Deviation 27.16 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day4; n= 25,27,0,0,0,0 | 7.6 millimeter of mercury (mmHg) | Standard Deviation 21.76 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day2; n=0,0,2,3,4,4 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day3; n= 29,31,1,1,0,0 | 5.1 millimeter of mercury (mmHg) | Standard Deviation 28.06 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day3; n= 0,0,2,3,3,4 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day2; n= 33,38,2,2,0,0 | 3.7 millimeter of mercury (mmHg) | Standard Deviation 22.66 |
| Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day4; n= 0,0,2,2,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day3; n= 29,31,1,1,0,0 | 4.9 millimeter of mercury (mmHg) | Standard Deviation 25 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day4; n= 0,0,2,2,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day6; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Follow up; n= 27,28,3,3,4,2 | 6.7 millimeter of mercury (mmHg) | Standard Deviation 13.7 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day6; n= 18,19,0,0,0,0 | 2.3 millimeter of mercury (mmHg) | Standard Deviation 15.86 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day3; n= 0,0,2,3,3,4 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day5; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day4; n= 25,27,0,0,0,0 | 6.0 millimeter of mercury (mmHg) | Standard Deviation 30.02 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day7; n= 14,14,0,0,0,0 | -5.4 millimeter of mercury (mmHg) | Standard Deviation 24.47 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day6; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day2; n= 33,38,2,2,0,0 | 1.4 millimeter of mercury (mmHg) | Standard Deviation 23.55 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day1; n= 23,33,1,3,0,0 | 1.0 millimeter of mercury (mmHg) | Standard Deviation 24.37 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day3; n= 29,31,1,1,0,0 | 1.7 millimeter of mercury (mmHg) | Standard Deviation 10.44 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP follow up; n= 27,28,3,3,4,2 | -1.4 millimeter of mercury (mmHg) | Standard Deviation 30.61 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day5; n= 0,0,2,1,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day7; n= 14,14,0,0,0,0 | -2.4 millimeter of mercury (mmHg) | Standard Deviation 13.89 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day4; n= 0,0,2,2,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day2; n= 33,38,2,2,0,0 | -0.2 millimeter of mercury (mmHg) | Standard Deviation 11.66 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day4; n=25,27,0,0,0,0 | 3.2 millimeter of mercury (mmHg) | Standard Deviation 13.37 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day6; n= 18,19,0,0,0,0 | -4.2 millimeter of mercury (mmHg) | Standard Deviation 33.26 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day2; n=0,0,2,3,4,4 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day3; n= 0,0,2,3,3,4 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day5; n= 22,23,0,0,0,0 | -0.6 millimeter of mercury (mmHg) | Standard Deviation 34.31 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day1; n= 23,33,1,3,0,0 | -1.0 millimeter of mercury (mmHg) | Standard Deviation 9.84 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day5; n= 22,23,0,0,0,0 | -0.7 millimeter of mercury (mmHg) | Standard Deviation 15.66 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day2; n= 0,0,2,3,4,4 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day1; n=1,0,3,3,3,3 | NA millimeter of mercury (mmHg) | — |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day1; n= 1,0,3,3,3,3 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day1; n=1,0,3,3,3,3 | 9.3 millimeter of mercury (mmHg) | Standard Deviation 4.04 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day1; n= 23,33,1,3,0,0 | 5.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day2; n= 33,38,2,2,0,0 | -1.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day3; n= 29,31,1,1,0,0 | 5.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day4; n=25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day2; n=0,0,2,3,4,4 | 4.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day3; n= 0,0,2,3,3,4 | 10.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day4; n= 0,0,2,2,3,3 | 9.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day5; n= 0,0,2,1,3,3 | -5.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day6; n= 0,0,2,1,3,3 | 14.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Follow up; n= 27,28,3,3,4,2 | 23.0 millimeter of mercury (mmHg) | Standard Deviation 6.08 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day1; n= 23,33,1,3,0,0 | 1.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day2; n= 33,38,2,2,0,0 | 12.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day3; n= 29,31,1,1,0,0 | 6.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day4; n= 25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day1; n= 1,0,3,3,3,3 | 16.3 millimeter of mercury (mmHg) | Standard Deviation 12.66 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day2; n= 0,0,2,3,4,4 | 4.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day3; n= 0,0,2,3,3,4 | 11.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day4; n= 0,0,2,2,3,3 | 19.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day5; n= 0,0,2,1,3,3 | 17.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day6; n= 0,0,2,1,3,3 | 46.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP follow up; n= 27,28,3,3,4,2 | 26.0 millimeter of mercury (mmHg) | Standard Deviation 17.58 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day6; n= 0,0,2,1,3,3 | 5.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day4; n= 0,0,2,2,3,3 | 15.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Follow up; n= 27,28,3,3,4,2 | 18.0 millimeter of mercury (mmHg) | Standard Deviation 4.58 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day4; n=25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day3; n= 0,0,2,3,3,4 | 16.3 millimeter of mercury (mmHg) | Standard Deviation 22.37 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day2; n=0,0,2,3,4,4 | -12.0 millimeter of mercury (mmHg) | Standard Deviation 6.24 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day7; n= 0,0,0,0,3,2 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day2; n= 0,0,2,3,4,4 | -9.3 millimeter of mercury (mmHg) | Standard Deviation 10.6 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day3; n= 29,31,1,1,0,0 | -16.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day1; n= 1,0,3,3,3,3 | 1.7 millimeter of mercury (mmHg) | Standard Deviation 11.5 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day3; n= 0,0,2,3,3,4 | 6.3 millimeter of mercury (mmHg) | Standard Deviation 9.07 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day5; n= 0,0,2,1,3,3 | 2.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day6; n= 0,0,2,1,3,3 | -3.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP follow up; n= 27,28,3,3,4,2 | 3.0 millimeter of mercury (mmHg) | Standard Deviation 28.51 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day2; n= 33,38,2,2,0,0 | 6.5 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day4; n= 25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day1; n= 23,33,1,3,0,0 | 3.0 millimeter of mercury (mmHg) | Standard Deviation 23.64 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day5; n= 0,0,2,1,3,3 | 15.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day1; n=1,0,3,3,3,3 | -0.3 millimeter of mercury (mmHg) | Standard Deviation 11.27 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day3; n= 29,31,1,1,0,0 | -16.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day4; n= 0,0,2,2,3,3 | 22.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day2; n= 33,38,2,2,0,0 | 16.0 millimeter of mercury (mmHg) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day1; n= 23,33,1,3,0,0 | -2.0 millimeter of mercury (mmHg) | Standard Deviation 13.89 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day1; n= 23,33,1,3,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day3; n= 0,0,2,3,3,4 | 4.3 millimeter of mercury (mmHg) | Standard Deviation 8.39 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day1; n= 23,33,1,3,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day6; n= 0,0,2,1,3,3 | 20.3 millimeter of mercury (mmHg) | Standard Deviation 21.73 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day2; n= 33,38,2,2,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day2; n=0,0,2,3,4,4 | 23.5 millimeter of mercury (mmHg) | Standard Deviation 17.71 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day3; n= 29,31,1,1,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day1; n=1,0,3,3,3,3 | 11.0 millimeter of mercury (mmHg) | Standard Deviation 7.81 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day4; n= 25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP follow up; n= 27,28,3,3,4,2 | 11.8 millimeter of mercury (mmHg) | Standard Deviation 18.14 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day7; n= 0,0,0,0,3,2 | 22.0 millimeter of mercury (mmHg) | Standard Deviation 11.36 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day1; n= 1,0,3,3,3,3 | 1.0 millimeter of mercury (mmHg) | Standard Deviation 13.08 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day2; n= 0,0,2,3,4,4 | 32.8 millimeter of mercury (mmHg) | Standard Deviation 31.06 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day4; n=25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day3; n= 0,0,2,3,3,4 | 30.7 millimeter of mercury (mmHg) | Standard Deviation 12.22 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day4; n= 0,0,2,2,3,3 | 43.0 millimeter of mercury (mmHg) | Standard Deviation 16.52 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day3; n= 29,31,1,1,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day5; n= 0,0,2,1,3,3 | 19.7 millimeter of mercury (mmHg) | Standard Deviation 24.79 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day5; n= 0,0,2,1,3,3 | 5.3 millimeter of mercury (mmHg) | Standard Deviation 4.51 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day6; n= 0,0,2,1,3,3 | 7.3 millimeter of mercury (mmHg) | Standard Deviation 4.62 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day2; n= 33,38,2,2,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day7; n= 0,0,0,0,3,2 | 7.7 millimeter of mercury (mmHg) | Standard Deviation 7.51 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day4; n= 0,0,2,2,3,3 | 11.7 millimeter of mercury (mmHg) | Standard Deviation 8.5 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Follow up; n= 27,28,3,3,4,2 | 4.0 millimeter of mercury (mmHg) | Standard Deviation 6.98 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day3; n= 29,31,1,1,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day1; n= 23,33,1,3,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day6; n= 0,0,2,1,3,3 | 10.7 millimeter of mercury (mmHg) | Standard Deviation 10.41 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day4; n= 0,0,2,2,3,3 | -9.0 millimeter of mercury (mmHg) | Standard Deviation 12.29 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day1; n= 23,33,1,3,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP follow up; n= 27,28,3,3,4,2 | 14.0 millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day4; n= 25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day7; n= 0,0,0,0,3,2 | 8.5 millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day5; n= 0,0,2,1,3,3 | 8.7 millimeter of mercury (mmHg) | Standard Deviation 7.02 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day5; n= 0,0,2,1,3,3 | 1.7 millimeter of mercury (mmHg) | Standard Deviation 18.5 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Follow up; n= 27,28,3,3,4,2 | 29.0 millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day2; n= 33,38,2,2,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day1; n=1,0,3,3,3,3 | 0.0 millimeter of mercury (mmHg) | Standard Deviation 14.42 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day2; n= 33,38,2,2,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day1; n= 1,0,3,3,3,3 | -4.7 millimeter of mercury (mmHg) | Standard Deviation 9.07 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day6; n= 0,0,2,1,3,3 | 13.7 millimeter of mercury (mmHg) | Standard Deviation 25.97 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day5; n= 22,23,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day7; n= 0,0,0,0,3,2 | 13.0 millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day7; n= 14,14,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Day3; n= 29,31,1,1,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day2; n= 0,0,2,3,4,4 | -4.0 millimeter of mercury (mmHg) | Standard Deviation 7.79 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day4; n=25,27,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day4; n= 0,0,2,2,3,3 | -1.7 millimeter of mercury (mmHg) | Standard Deviation 9.24 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day3; n= 0,0,2,3,3,4 | -0.5 millimeter of mercury (mmHg) | Standard Deviation 4.36 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Day6; n= 18,19,0,0,0,0 | NA millimeter of mercury (mmHg) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP Intolerance Day2; n=0,0,2,3,4,4 | -4.0 millimeter of mercury (mmHg) | Standard Deviation 15.08 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP Intolerance Day3; n= 0,0,2,3,3,4 | 13.0 millimeter of mercury (mmHg) | Standard Deviation 21.18 |
Secondary
Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels
Blood samples were collected to evaluate change from Baseline in total and direct bilirubin, creatinine and uric acid values at Baseline, Day 2- Day 7 and at follow up (Till Day 23). Blood samples were also collected on Day 9 for those participants who completed 7 days of dosing. Change from Baseline was defined as post dose visit value minus Baseline value. For participants who developed intolerance, blood samples were taken for Day 1 to Day 7 up to 6 hrs prior to dosing. NA indicates that data were not available. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles). If n \< 3 the SD was set to missing.
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day7; 11,11,0,0,0,0 | -20.18 micromoles per Liter (µmol/L) | Standard Deviation 108.547 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; follow up; n= 13,15,2,2,2,2 | -1.969 micromoles per Liter (µmol/L) | Standard Deviation 3.6992 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day6; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day2; n= 32,35,2,2,0,0 | -1.172 micromoles per Liter (µmol/L) | Standard Deviation 4.406 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0 | -1.000 micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day7; n= 14,12,0,0,0,0 | 2.964 micromoles per Liter (µmol/L) | Standard Deviation 17.774 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day3; n= 29,30,1,1,0,0 | -1.038 micromoles per Liter (µmol/L) | Standard Deviation 3.6544 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day6; n= 18,19,0,0,0,0 | 0.772 micromoles per Liter (µmol/L) | Standard Deviation 11.3841 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day4; n= 25,25,0,0,0,0 | 0.496 micromoles per Liter (µmol/L) | Standard Deviation 8.6799 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day5; n=22,22,0,0,0,0 | 1.168 micromoles per Liter (µmol/L) | Standard Deviation 12.9402 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day5; n= 0,2,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day7; n= 0,0,1,0,1,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day7; n= 14,15,0,0,0,0 | -7.5714 micromoles per Liter (µmol/L) | Standard Deviation 26.46831 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day6; n= 0,0,0,1,1,0 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day3; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; follow up; n= 25,28,3,3,4,2 | -5.8400 micromoles per Liter (µmol/L) | Standard Deviation 20.46477 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day7; n= 0,0,1,0,3,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day3; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day6; n= 0,0,2,1,3,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid follow up; n= 15,14,2,3,3,2 | 60.47 micromoles per Liter (µmol/L) | Standard Deviation 96.092 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day 2; n= 28,26,2,1,0,0 | -1.246 micromoles per Liter (µmol/L) | Standard Deviation 3.7551 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day5; n= 0,0,2,1,3,3 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin Day3; n= 25,23,1,1,0,0 | -1.512 micromoles per Liter (µmol/L) | Standard Deviation 3.842 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day4; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day4; n= 0,0,2,2,3,3 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day3; n= 0,0,2,3,3,4 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day2; n= 0,0,3,3,4,4 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day5; n= 17,15,0,0,0,0 | 1.482 micromoles per Liter (µmol/L) | Standard Deviation 10.6636 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day1; n= 1,0,2,3,0,0 | -11.0000 micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day6; n= 13,12,0,0,0,0 | 1.031 micromoles per Liter (µmol/L) | Standard Deviation 9.5551 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day2; n= 0,0,0,0,0,1 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day6; n= 18,19,0,0,0,0 | -7.5000 micromoles per Liter (µmol/L) | Standard Deviation 21.34658 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day5; n= 22,22,0,0,0,0 | -7.0909 micromoles per Liter (µmol/L) | Standard Deviation 16.52389 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day7; n= 10,7,0,0,0,0 | 3.240 micromoles per Liter (µmol/L) | Standard Deviation 16.6513 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day4; n= 25,26,0,0,0,0 | -6.2400 micromoles per Liter (µmol/L) | Standard Deviation 14.29534 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0 | 0.000 micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day4; n= 19,18,0,0,0,0 | 0.700 micromoles per Liter (µmol/L) | Standard Deviation 6.2765 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day3; n= 29,31,1,1,0,0 | -4.2724 micromoles per Liter (µmol/L) | Standard Deviation 16.74713 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day2; n= 33,37,2,2,0,0 | -2.1818 micromoles per Liter (µmol/L) | Standard Deviation 9.34898 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; follow up; n= 19,20,3,2,4,2 | -1.263 micromoles per Liter (µmol/L) | Standard Deviation 4.8442 |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3 | NA micromoles per Liter (µmol/L) | — |
| Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day4; n= 0,0,2,2,3,3 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day3; n= 29,31,1,1,0,0 | -5.0323 micromoles per Liter (µmol/L) | Standard Deviation 22.15774 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; follow up; n= 13,15,2,2,2,2 | -1.507 micromoles per Liter (µmol/L) | Standard Deviation 4.2699 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin Day3; n= 25,23,1,1,0,0 | -0.126 micromoles per Liter (µmol/L) | Standard Deviation 3.2325 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid follow up; n= 15,14,2,3,3,2 | 58.36 micromoles per Liter (µmol/L) | Standard Deviation 144.871 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day2; n= 0,0,3,3,4,4 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day7; n= 14,12,0,0,0,0 | -3.133 micromoles per Liter (µmol/L) | Standard Deviation 10.6133 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day6; n= 13,12,0,0,0,0 | -0.583 micromoles per Liter (µmol/L) | Standard Deviation 2.5933 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day1; n= 1,0,2,3,0,0 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day3; n= 29,30,1,1,0,0 | -0.660 micromoles per Liter (µmol/L) | Standard Deviation 7.4569 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day7; n= 10,7,0,0,0,0 | -1.214 micromoles per Liter (µmol/L) | Standard Deviation 4.9229 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day6; n= 18,19,0,0,0,0 | -1.558 micromoles per Liter (µmol/L) | Standard Deviation 7.2077 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day2; n= 33,37,2,2,0,0 | -1.4281 micromoles per Liter (µmol/L) | Standard Deviation 28.09838 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day5; n=22,22,0,0,0,0 | -1.055 micromoles per Liter (µmol/L) | Standard Deviation 6.5842 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day5; n= 17,15,0,0,0,0 | -1.007 micromoles per Liter (µmol/L) | Standard Deviation 4.7148 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day4; n= 25,25,0,0,0,0 | -0.840 micromoles per Liter (µmol/L) | Standard Deviation 7.1559 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day5; n= 0,2,0,0,0,0 | -20.00 micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day2; n= 0,0,0,0,0,1 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day7; n= 0,0,1,0,1,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day7; n= 14,15,0,0,0,0 | 6.4000 micromoles per Liter (µmol/L) | Standard Deviation 78.29322 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day3; n= 0,1,0,0,0,0 | -70.00 micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day6; n= 18,19,0,0,0,0 | 19.7895 micromoles per Liter (µmol/L) | Standard Deviation 83.59198 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day3; n= 0,0,2,3,3,4 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; follow up; n= 19,20,3,2,4,2 | -1.805 micromoles per Liter (µmol/L) | Standard Deviation 8.3199 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; follow up; n= 25,28,3,3,4,2 | 11.6786 micromoles per Liter (µmol/L) | Standard Deviation 103.906 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day5; n= 22,22,0,0,0,0 | 1.5909 micromoles per Liter (µmol/L) | Standard Deviation 52.62053 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day6; n= 0,1,0,0,0,0 | 282.00 micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day4; n= 19,18,0,0,0,0 | 0.172 micromoles per Liter (µmol/L) | Standard Deviation 1.3323 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day7; n= 0,0,1,0,3,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day3; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day4; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day6; n= 0,0,0,1,1,0 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day6; n= 0,0,2,1,3,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day7; 11,11,0,0,0,0 | -15.36 micromoles per Liter (µmol/L) | Standard Deviation 152.55 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day4; n= 25,26,0,0,0,0 | -3.6923 micromoles per Liter (µmol/L) | Standard Deviation 32.58683 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day2; n= 32,35,2,2,0,0 | 0.326 micromoles per Liter (µmol/L) | Standard Deviation 4.0836 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day 2; n= 28,26,2,1,0,0 | 0.088 micromoles per Liter (µmol/L) | Standard Deviation 2.8035 |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2 | NA micromoles per Liter (µmol/L) | — |
| Placebo | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day5; n= 0,0,2,1,3,3 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0 | 7.100 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day4; n= 19,18,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3 | 1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2 | -1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day5; n=22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0 | 6.700 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4 | 7.100 micromoles per Liter (µmol/L) | Standard Deviation 4.531 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day2; n= 33,37,2,2,0,0 | -13.5000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day5; n= 22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day2; n= 0,0,3,3,4,4 | -1.6667 micromoles per Liter (µmol/L) | Standard Deviation 10.06645 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; follow up; n= 25,28,3,3,4,2 | -34.0000 micromoles per Liter (µmol/L) | Standard Deviation 13.52775 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day6; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day 2; n= 28,26,2,1,0,0 | 0.800 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin Day3; n= 25,23,1,1,0,0 | 25.300 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day5; n= 17,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day6; n= 13,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day7; n= 10,7,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2 | 7.100 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2 | 5.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2 | 4.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2 | 1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; follow up; n= 13,15,2,2,2,2 | 0.100 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day2; n= 32,35,2,2,0,0 | -1.350 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day3; n= 29,30,1,1,0,0 | 25.700 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day4; n= 25,25,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day7; n= 14,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4 | 5.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3 | 5.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3 | 7.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2 | 7.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2 | 1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; follow up; n= 19,20,3,2,4,2 | -0.467 micromoles per Liter (µmol/L) | Standard Deviation 8.2978 |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day3; n= 29,31,1,1,0,0 | -3.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day4; n= 25,26,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day7; n= 14,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day1; n= 1,0,2,3,0,0 | 1.5000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day3; n= 0,0,2,3,3,4 | -5.5000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day4; n= 0,0,2,2,3,3 | -1.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day5; n= 0,0,2,1,3,3 | -23.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day6; n= 0,0,2,1,3,2 | -28.5000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day7; n= 0,0,1,0,3,2 | -50.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day3; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day5; n= 0,2,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day7; 11,11,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day2; n= 0,0,0,0,0,1 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day3; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day4; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day6; n= 0,0,0,1,1,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day7; n= 0,0,1,0,1,2 | -270.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid follow up; n= 15,14,2,3,3,2 | -25.50 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day5; n= 22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day6; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day6; n= 13,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day2; n= 0,0,0,0,0,1 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day4; n= 0,0,0,1,0,0 | 153.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day3; n= 0,0,0,1,0,0 | -20.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2 | -1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4 | 1.000 micromoles per Liter (µmol/L) | Standard Deviation 2.6458 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day7; n= 14,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day3; n= 29,30,1,1,0,0 | 1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day6; n= 0,0,2,1,3,2 | -10.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day5; n= 17,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day6; n= 0,0,0,1,1,0 | -20.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day 2; n= 28,26,2,1,0,0 | 1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day1; n= 1,0,2,3,0,0 | -1.6667 micromoles per Liter (µmol/L) | Standard Deviation 3.51188 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day5; n=22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day4; n= 0,0,2,2,3,3 | -6.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day4; n= 25,25,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid follow up; n= 15,14,2,3,3,2 | 115.67 micromoles per Liter (µmol/L) | Standard Deviation 106.228 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day2; n= 0,0,3,3,4,4 | -5.6667 micromoles per Liter (µmol/L) | Standard Deviation 5.1316 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3 | 3.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin Day3; n= 25,23,1,1,0,0 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day3; n= 0,0,2,3,3,4 | -4.6667 micromoles per Liter (µmol/L) | Standard Deviation 5.50757 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; follow up; n= 13,15,2,2,2,2 | -0.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day7; 11,11,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day2; n= 32,35,2,2,0,0 | 0.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3 | 0.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day7; n= 0,0,1,0,1,2 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; follow up; n= 19,20,3,2,4,2 | -2.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day7; n= 14,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day5; n= 0,2,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4 | 0.333 micromoles per Liter (µmol/L) | Standard Deviation 3.2146 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day2; n= 33,37,2,2,0,0 | -5.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day4; n= 19,18,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0 | 0.667 micromoles per Liter (µmol/L) | Standard Deviation 2.5166 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2 | 1.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day3; n= 29,31,1,1,0,0 | -3.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day3; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day7; n= 10,7,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day5; n= 0,0,2,1,3,3 | -10.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day4; n= 25,26,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; follow up; n= 25,28,3,3,4,2 | -4.0000 micromoles per Liter (µmol/L) | Standard Deviation 11.35782 |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day7; n= 0,0,1,0,3,2 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day5; n= 0,2,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4 | 0.167 micromoles per Liter (µmol/L) | Standard Deviation 0.7638 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2 | 0.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3 | 0.833 micromoles per Liter (µmol/L) | Standard Deviation 2.7538 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2 | -0.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3 | 0.633 micromoles per Liter (µmol/L) | Standard Deviation 2.0984 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2 | 0.000 micromoles per Liter (µmol/L) | Standard Deviation 2 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day3; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2 | -0.800 micromoles per Liter (µmol/L) | Standard Deviation 2.3065 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; follow up; n= 19,20,3,2,4,2 | 10.850 micromoles per Liter (µmol/L) | Standard Deviation 25.5152 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day2; n= 33,37,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day3; n= 29,31,1,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day7; n= 10,7,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day4; n= 25,26,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day6; n= 13,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day5; n= 22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day5; n= 17,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day4; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day7; n= 14,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day1; n= 1,0,2,3,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day4; n= 19,18,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day2; n= 0,0,3,3,4,4 | 5.7500 micromoles per Liter (µmol/L) | Standard Deviation 20.79062 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin Day3; n= 25,23,1,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day3; n= 0,0,2,3,3,4 | 3.3333 micromoles per Liter (µmol/L) | Standard Deviation 36.29509 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day4; n= 0,0,2,2,3,3 | -13.0000 micromoles per Liter (µmol/L) | Standard Deviation 30.34798 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day 2; n= 28,26,2,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day6; n= 0,0,0,1,1,0 | 27.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day5; n= 0,0,2,1,3,3 | -11.3333 micromoles per Liter (µmol/L) | Standard Deviation 27.15388 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day6; n= 0,0,2,1,3,2 | -12.3333 micromoles per Liter (µmol/L) | Standard Deviation 34.93327 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day7; n= 0,0,1,0,3,2 | -4.3333 micromoles per Liter (µmol/L) | Standard Deviation 48.33563 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; follow up; n= 25,28,3,3,4,2 | -12.0000 micromoles per Liter (µmol/L) | Standard Deviation 24.17988 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day3; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid follow up; n= 15,14,2,3,3,2 | 72.33 micromoles per Liter (µmol/L) | Standard Deviation 118.095 |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day2; n= 0,0,0,0,0,1 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day6; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day7; n= 14,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day7; 11,11,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2 | 0.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day4; n= 25,25,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day5; n=22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day3; n= 29,30,1,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2 | 0.500 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day2; n= 32,35,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day7; n= 0,0,1,0,1,2 | -100.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; follow up; n= 13,15,2,2,2,2 | 16.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Camicinal 50 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4 | -0.075 micromoles per Liter (µmol/L) | Standard Deviation 1.0751 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day4; n= 25,26,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; follow up; n= 13,15,2,2,2,2 | -15.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; follow up; n= 25,28,3,3,4,2 | -39.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid follow up; n= 15,14,2,3,3,2 | 1076.90 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day7; n= 10,7,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day3; n= 29,31,1,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day5; n= 0,0,2,1,3,3 | -1.100 micromoles per Liter (µmol/L) | Standard Deviation 4.2579 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day3; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; follow up; n= 19,20,3,2,4,2 | -17.000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day2; n= 33,37,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day3; n= 0,0,2,3,3,4 | 10.475 micromoles per Liter (µmol/L) | Standard Deviation 19.6274 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day2; n= 0,0,2,1,2,2 | 1.700 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day6; n= 18,19,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day5; n= 0,2,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day7; n= 14,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day2; n= 32,35,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day6; n= 0,1,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day2; n= 0,0,0,0,0,1 | -3640.00 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day5; n= 0,0,1,1,2,2 | -1.050 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day3; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day7; n= 0,0,1,0,3,2 | -9.250 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day7; n= 0,0,1,0,2,2 | -8.050 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; Day7; 11,11,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day6; n=0,0,1,0,2,2 | -7.100 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day4; n= 0,0,2,2,3,3 | 3.333 micromoles per Liter (µmol/L) | Standard Deviation 4.9329 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day1; n= 1,0,2,2,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day4; n= 25,25,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day3; n= 0,0,2,3,3,4 | -21.5000 micromoles per Liter (µmol/L) | Standard Deviation 22.60531 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day2; n= 0,0,3,3,4,4 | -1.5000 micromoles per Liter (µmol/L) | Standard Deviation 11.90238 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day 2; n= 28,26,2,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin Day3; n= 25,23,1,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day1; n= 1,0,2,3,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day3; n= 0,0,1,2,1,3 | 12.167 micromoles per Liter (µmol/L) | Standard Deviation 19.9144 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day4; n= 0,0,2,2,3,3 | -14.0000 micromoles per Liter (µmol/L) | Standard Deviation 22.60531 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day3; n= 29,30,1,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day4; n= 0,0,0,1,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; intolerance Day4; n= 0,0,1,1,2,2 | 4.800 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day2; n= 0,0,3,3,4,4 | 4.675 micromoles per Liter (µmol/L) | Standard Deviation 6.6249 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day5; n= 0,0,2,1,3,3 | -16.6667 micromoles per Liter (µmol/L) | Standard Deviation 20.59935 |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day7; n= 0,0,1,0,1,2 | 60.40 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day4; n= 19,18,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Uric acid; intolerance Day6; n= 0,0,0,1,1,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day7; n= 14,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; Day5; n=22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day6; n= 0,0,2,1,3,2 | -32.5000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day5; n= 17,15,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; Day5; n= 22,22,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day1; n= 1,0,2,3,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Direct bilirubin; Day6; n= 13,12,0,0,0,0 | NA micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Creatinine; intolerance Day7; n= 0,0,1,0,3,2 | -34.0000 micromoles per Liter (µmol/L) | — |
| Baseline EN Intolerant: Metoclopramide 10 mg | Change From Baseline in Total and Direct Bilirubin, Creatinine and Uric Acid Levels | Total bilirubin; intolerance Day6; n= 0,0,2,1,3,2 | -8.050 micromoles per Liter (µmol/L) | — |
Secondary
Derived Accumulation Ratio (RO) of GSK962040 Post Intolerance
To estimate the extent of accumulation after repeat dosing, the observed accumulation ratio (Ro) was assessed.
Time frame: Baseline, Day 2, Day 3, Day 4
Population: PK Population. data were not collected.
Secondary
Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Baseline, and at Day 2 and Day 4 post development of intolerance. AUC from time zero extrapolated to infinite time \[AUC(0-inf)\] was not analyzed.
Time frame: Day 2 and Day 4
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance | Intolerance Day 2 | 792.8 min*mmol/l |
| Camicinal 50 mg | Derived AUC Over the Dosing Period [AUC(0-tau)] of GSK962040 Post Intolerance | Intolerance Day 4 | 2698.8 min*mmol/l |
Secondary
Derived Tmax of 3-OMG Post Intolerance
Blood samples for PK analysis were collected at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained) post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of 3-OMG.
Time frame: At Day 2
Population: PK Population. Data for Tmax was not collected.
Secondary
Derived Tmax of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Tmax was defined as time to maximum observed plasma concentration of Camicinal.NA indicates that data were not available. SD was not provided if n\<3.
Time frame: Day 2 and Day 4
Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Camicinal 50 mg | Derived Tmax of GSK962040 Post Intolerance | Intolerance Day 2; n= 2 | 2.717 Hr |
| Camicinal 50 mg | Derived Tmax of GSK962040 Post Intolerance | Intolerance day 4; n= 1 | 1.500 Hr |
Secondary
GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. AUC(0-60) and AUC (0-240) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Time frame: Baseline, Day 2, Day 3, Day 4
Population: ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | AUC(0-240); n= 36, 33 | 31.4065 min*mmol/l |
| Camicinal 50 mg | GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | AUC(0-60); n= 38, 34 | 3.3709 min*mmol/l |
| Placebo | GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | AUC(0-60); n= 38, 34 | 3.8341 min*mmol/l |
| Placebo | GE Assessment as AUC (0-60) and AUC (0-240) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | AUC(0-240); n= 36, 33 | 26.4060 min*mmol/l |
Secondary
GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. AUC (0-60) was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Time frame: Day 2
Population: ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Camicinal 50 mg | GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen | 192321.7 min*ng/mL |
| Placebo | GE Assessment as AUC (0-60) Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen | 222411.3 min*ng/mL |
Secondary
GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using 3-OMG absorption method. C60 was calculated and data was presented for pre-dose Visit (day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Time frame: Baseline, Day 2, Day 3, Day 4
Population: ITT (exposed) Population. Only those participants available at the pre-dose visit were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Camicinal 50 mg | GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | 0.12547 mmol/l |
| Placebo | GE Assessment as C60 Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using 3-OMG | 0.12856 mmol/l |
Secondary
GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen
GE assessment within 24 hrs of developing intolerance and prior to change of treatment was analyzed using acetaminophen absorption method. Cmax was calculated and data was presented for pre-dose Visit(day prior to change of treatment). Geometric mean and 95 percent CI was analyzed.
Time frame: Baseline, Day 2, Day 3, Day 4
Population: ITT (exposed) Population. Only those participants with data available at pre-dose visit were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Camicinal 50 mg | GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen | 5482.09 ng/mL |
| Placebo | GE Assessment as Cmax Within 24 Hrs of Developing Intolerance and Prior to Change of Treatment Using Acetaminophen | 6068.34 ng/mL |
Secondary
Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG)
Blood samples for PK analysis were collected at Baseline, and at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC\[0-60\] of 3-OMG was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
Time frame: At Day 2
Population: ITT (exposed) Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) | Pre-dose; n=38,34 | 3.3709 Log [Min. into mmol/L (min*mmol/l)] |
| Camicinal 50 mg | Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) | Post-dose; n= 32,27 | 7.2872 Log [Min. into mmol/L (min*mmol/l)] |
| Placebo | Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) | Pre-dose; n=38,34 | 3.8341 Log [Min. into mmol/L (min*mmol/l)] |
| Placebo | Log Transformed AUC[0-60] of 3-O-methylglucose (3- OMG) | Post-dose; n= 32,27 | 6.1047 Log [Min. into mmol/L (min*mmol/l)] |
Secondary
Log Transformed AUC[0-60] of Acetaminophen
Blood samples for PK analysis were collected at Baseline, and at 60 min. at Day 2 or Day 3 (or very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. AUC\[0-60\] of acetaminophen was defined as area under the concentration-time curve from time zero to 60 min. and it was calculated as Log trapezoidal rule from concentration-time data. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
Time frame: At Day 2
Population: ITT (exposed) Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Log Transformed AUC[0-60] of Acetaminophen | Pre-dose; n=42,36 | 192321.7 Log [min into ng/mL (min*ng/mL)] |
| Camicinal 50 mg | Log Transformed AUC[0-60] of Acetaminophen | Post-dose; n= 33,27 | 234538.9 Log [min into ng/mL (min*ng/mL)] |
| Placebo | Log Transformed AUC[0-60] of Acetaminophen | Pre-dose; n=42,36 | 222411.3 Log [min into ng/mL (min*ng/mL)] |
| Placebo | Log Transformed AUC[0-60] of Acetaminophen | Post-dose; n= 33,27 | 228473.7 Log [min into ng/mL (min*ng/mL)] |
Secondary
Log Transformed C60 of 3-OMG
Blood samples for PK analysis were collected at Baseline and at Day 2 or Day 3 (or very rarely at Day 4 - only if Day 2 or Day 3 sample could not be obtained)prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with 3-OMG. The absorption profile of 3-OMG was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Cmax was not analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Time frame: At Day 2
Population: ITT (exposed) Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Log Transformed C60 of 3-OMG | C60; Pre-dose | 0.12547 Log (mmol/L) |
| Camicinal 50 mg | Log Transformed C60 of 3-OMG | C60; post-dose | 0.19960 Log (mmol/L) |
| Placebo | Log Transformed C60 of 3-OMG | C60; Pre-dose | 0.12856 Log (mmol/L) |
| Placebo | Log Transformed C60 of 3-OMG | C60; post-dose | 0.18723 Log (mmol/L) |
Secondary
Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance)
Blood samples for pharmacokinetic (PK) analysis were collected at Baseline, and at Day 2 or at Day 3 (OR very rarely Day 4 - only if Day 2 or Day 3 sample could not be obtained) prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. C60 was defined as observed plasma concentration at 60 min after administration of enteral feed with acetaminophen and Cmax was defined as maximum observed plasma concentration of acetaminophen. The absorption profile of acetaminophen was used as an indirect measure of gastric emptying function. The analysis was performed on ITT (exposed) Population. Due to change in sampling schedule, samples were only obtained to 4 hours. Only those participants available at the specified time points were analyzed (represented by n= x in the category titles).
Time frame: At Day 2
Population: ITT (exposed) Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | C60; Pre-dose; n= 42,36 | 4108.99 Log [nanogram per milliliter (ng/mL)] |
| Camicinal 50 mg | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | C60; post-dose; n= 33,27 | 4504.30 Log [nanogram per milliliter (ng/mL)] |
| Camicinal 50 mg | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | Cmax; pre-dose; n= 42,36 | 5482.09 Log [nanogram per milliliter (ng/mL)] |
| Camicinal 50 mg | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | Cmax; post-dose; n= 33,27 | 6576.47 Log [nanogram per milliliter (ng/mL)] |
| Placebo | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | Cmax; post-dose; n= 33,27 | 6319.73 Log [nanogram per milliliter (ng/mL)] |
| Placebo | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | C60; Pre-dose; n= 42,36 | 4374.35 Log [nanogram per milliliter (ng/mL)] |
| Placebo | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | Cmax; pre-dose; n= 42,36 | 6068.34 Log [nanogram per milliliter (ng/mL)] |
| Placebo | Log Transformed Concentration at 60 Minutes (Min) (C60) and Maximum Observed Concentration (Cmax) of Acetaminophen (Prior to Intolerance) | C60; post-dose; n= 33,27 | 4691.64 Log [nanogram per milliliter (ng/mL)] |
Secondary
Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance
Blood samples for PK analysis were collected at Day 2 and Day 4 post development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. NA indicates that data were not available. SD was not provided if n \< 3.
Time frame: Day 2 and Day 4
Population: PK Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance | Intolerance Day 2; n= 2 | 168.56 Log (ng/mL) |
| Camicinal 50 mg | Log Transformed Derived Plasma Cmax of GSK962040 Post Intolerance | Intolerance Day 4; n= 1 | 704.40 Log (ng/mL) |
Secondary
Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance
Blood samples for PK analysis were collected at Day 2, Day 3, Day 4, Day 7 prior to intolerance. Prior to intolerance was defined as prior to development of intolerance. Cmax was defined as maximum observed plasma concentration of Camicinal. The analysis was performed on PK Population. PK Population comprised of participants in the 'Safety' population for whom a PK sample of Camicinal was obtained and analyzed. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Time frame: Day 2, Day 3, Day 4, Day 7
Population: PK Population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Camicinal 50 mg | Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance | Day 2; n= 25 | 952.55 Log (ng/mL) |
| Camicinal 50 mg | Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance | Day 3; n=3 | 748.28 Log (ng/mL) |
| Camicinal 50 mg | Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance | Day 4; n= 5 | 1722.74 Log (ng/mL) |
| Camicinal 50 mg | Log Transformed Derived Plasma Cmax of GSK962040 Prior to Intolerance | Day 7; n= 5 | 1206.67 Log (ng/mL) |
Secondary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment or all events of possible drug-induced liver injury with hyperbilirubinaemia were categorized as SAE.
Time frame: up to 23 days
Population: Safety Population. Safety Population comprised of all participants who received at least one dose one study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Camicinal 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 1 Participants |
| Camicinal 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 9 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 4 Participants |
| Placebo | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 13 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE | 3 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAE | 2 Participants |
Secondary
Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values
12-lead ECGs was done at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7 and at follow up (till Day 23) that automatically calculates corrected QT (QTc), QTcF (QT duration corrected for heart rate by Fridericia's formula) and QTcB (QT duration corrected for heart rate by Bazett's formula) intervals. Three ECGs approximately 5 min apart were collected prior to dose 1and single recordings were made at other time points. On Day 1ECGs were collected at pre-dose (up to 6 hrs) and 2 hr post treatment. Number of participants with maximum increase from Baseline were collected and participants showed increase in 3 parameters namely QTc, QTcB and QTcF. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).
Time frame: Up to 23 days
Population: Safety Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; >60; n= 5,4,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB <=60; n= 23,28,2,1,0,0 | 23 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; <=60; n= 16,19,0,0,0,0 | 16 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; >60; n= 5,5,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB >60; n= 23,28,2,1,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; <=60; n= 8,11,0,0,0,0 | 8 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; <=60; n= 16,19,0,0,0,0 | 16 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF <=60; n= 23,28,2,1,0,0 | 23 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; <=60; n= 11,14,0,0,0,0 | 11 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; <=60; n= 7,5,0,0,0,0 | 7 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; <=60; n= 11,14,0,0,0,0 | 11 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF >60; n= 23,28,2,1,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc >60; n= 7,6,0,1,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc <= 60; n= 7,6,0,1,0,0 | 7 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc <= 60; n= 10,5,0,1,0,0 | 10 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; >60; n= 19,21,1,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; <=60; n= 19,21,1,0,0,0 | 19 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB <=60; n= 23,28,3,2,0,0 | 23 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; <=60; n= 6,4,0,1,1,1 | 6 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB >60; n= 19,21,1,0,0 | 1 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB >60; n= 23,28,3,2,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB <=60; n= 19,21,1,0,0 | 18 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; <=60; n= 5,4,0,0,0,0 | 5 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; <=60; n= 5,5,0,0,0,0 | 5 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; <=60; n= 14,17,0,0,0,0 | 14 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; >60; n= 10,13,2,2,3,1 | 1 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc >60; n= 10,5,0,1,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; <=60; n= 8,11,0,0,0,0 | 8 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF <=60; n= 23,28,3,2,0,0 | 23 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF >60; n= 23,28,3,2,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF; >60; n= 10,13,2,2,2,1 | 1 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF;<=60; n= 10,13,2,2,2,1 | 9 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc <= 60; n= 8,7,0,1,0,0 | 8 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; >60; n= 6,4,0,1,1,1 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; <=60; n= 10,13,2,2,3,1 | 9 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; <=60; n= 14,17,0,0,0,0 | 14 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; <=60; n= 7,5,0,0,0,0 | 7 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc >60; n= 8,7,0,1,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB <=60; n= 23,28,3,2,0,0 | 27 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB >60; n= 23,28,3,2,0,0 | 1 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF <=60; n= 23,28,3,2,0,0 | 27 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF >60; n= 23,28,3,2,0,0 | 1 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc <= 60; n= 8,7,0,1,0,0 | 7 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc >60; n= 8,7,0,1,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; <=60; n= 7,5,0,0,0,0 | 5 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB <=60; n= 23,28,2,1,0,0 | 26 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB >60; n= 23,28,2,1,0,0 | 2 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF <=60; n= 23,28,2,1,0,0 | 27 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF >60; n= 23,28,2,1,0,0 | 1 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc >60; n= 7,6,0,1,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; <=60; n= 7,5,0,0,0,0 | 5 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; <=60; n= 16,19,0,0,0,0 | 19 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; <=60; n= 16,19,0,0,0,0 | 19 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; <=60; n= 14,17,0,0,0,0 | 17 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc <= 60; n= 7,6,0,1,0,0 | 6 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; <=60; n= 10,13,2,2,3,1 | 13 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF;<=60; n= 10,13,2,2,2,1 | 13 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF; >60; n= 10,13,2,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; >60; n= 10,13,2,2,3,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; >60; n= 14,17,0,0,0,0 | 1 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; <=60; n= 5,5,0,0,0,0 | 5 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; <=60; n= 5,4,0,0,0,0 | 4 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; >60; n= 5,4,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB <=60; n= 19,21,1,0,0 | 21 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB >60; n= 19,21,1,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; <=60; n= 19,21,1,0,0,0 | 21 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; >60; n= 19,21,1,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; <=60; n= 11,14,0,0,0,0 | 14 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; <=60; n= 14,17,0,0,0,0 | 16 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; <=60; n= 11,14,0,0,0,0 | 14 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc <= 60; n= 10,5,0,1,0,0 | 5 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; <=60; n= 8,11,0,0,0,0 | 11 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; >60; n= 5,5,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; <=60; n= 8,11,0,0,0,0 | 11 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; <=60; n= 6,4,0,1,1,1 | 4 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; >60; n= 6,4,0,1,1,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc >60; n= 10,5,0,1,0,0 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Placebo | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc <= 60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; <=60; n= 10,13,2,2,3,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; <=60; n= 6,4,0,1,1,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF;<=60; n= 10,13,2,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF; >60; n= 10,13,2,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF <=60; n= 23,28,2,1,0,0 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; >60; n= 6,4,0,1,1,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF <=60; n= 23,28,3,2,0,0 | 3 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1 | 3 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1 | 3 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1 | 3 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; >60; n= 10,13,2,2,3,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB <=60; n= 23,28,3,2,0,0 | 3 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; <=60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; <=60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB <=60; n= 19,21,1,0,0 | 1 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB >60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; <=60; n= 19,21,1,0,0,0 | 1 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc >60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; >60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1 | 3 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc <= 60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc >60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; >60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB <=60; n= 23,28,2,1,0,0 | 2 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc <= 60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc >60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; >60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc <= 60; n= 8,7,0,1,0,0 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; <=60; n= 10,13,2,2,3,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; >60; n= 10,13,2,2,3,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; <=60; n= 6,4,0,1,1,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; <=60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF;<=60; n= 10,13,2,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF; >60; n= 10,13,2,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc <= 60; n= 10,5,0,1,0,0 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; <=60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB <=60; n= 23,28,3,2,0,0 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF <=60; n= 23,28,3,2,0,0 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc >60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc >60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; >60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc <= 60; n= 7,6,0,1,0,0 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc >60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB <=60; n= 23,28,2,1,0,0 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; >60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; >60; n= 6,4,0,1,1,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1 | 2 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; >60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; <=60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB <=60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1 | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB >60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF <=60; n= 23,28,2,1,0,0 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; <=60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; >60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; <=60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; >60; n= 6,4,0,1,1,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc <= 60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc >60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB <=60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF <=60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc <= 60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc >60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB <=60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF <=60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc <= 60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc >60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; >60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; <=60; n= 10,13,2,2,3,1 | 3 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF;<=60; n= 10,13,2,2,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF; >60; n= 10,13,2,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1 | 3 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB <=60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB >60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; <=60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; >60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; <=60; n= 6,4,0,1,1,1 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1 | 3 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; >60; n= 10,13,2,2,3,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1 | 1 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1 | 2 Participants |
| Baseline EN Intolerant: Camicinal 50 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; <=60; n= 0,0,1,1,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; <=60; n= 0,0,3,2,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcB; <=60; n= 0,0,3,2,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc >60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcB; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTc; <=60; n= 0,0,0,1,1,2 | 2 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; <=60; n= 0,0,3,2,3,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; <=60; n= 6,4,0,1,1,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; <=60; n= 0,0,1,1,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; >60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcB; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; >60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTcF; >60; n= 0,0,1,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcB; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; <=60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; <=60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTc <= 60; n= 10,5,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; <=60; n= 0,0,0,0,1,2 | 2 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB >60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcB <=60; n= 19,21,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; <=60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTc; >60; n= 6,4,0,1,1,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTc; >60; n= 0,0,0,0,1,2 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcF; <=60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; <=60; n= 10,13,2,2,3,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcF; >60; n= 0,0,3,2,3,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTcF; <=60; n= 8,11,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTcB; <=60; n= 0,0,3,2,3,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 1; QTc; <=60; n=0,0,0,1,1,2 | 2 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF; >60; n= 10,13,2,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 7; QTc; <=60; n= 5,4,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcF;<=60; n= 10,13,2,2,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Follow up; QTcB; >60; n= 10,13,2,2,3,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; >60; n= 0,0,0,0,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcF; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; >60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTcB; <=60; n= 16,19,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcF; <=60; n= 0,0,0,0,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 6; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; >60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 4; QTc; <=60; n= 7,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTcF; >60; n= 19,21,1,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc >60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTcF; >60; n= 11,14,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; <=60; n= 0,0,0,0,1,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 3; QTc <= 60; n= 7,6,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcF <=60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB >60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 6; QTc; >60; n= 5,5,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTc; >60; n= 0,0,0,0,1,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTcB <=60; n= 23,28,2,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc >60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 2; QTc <= 60; n= 8,7,0,1,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 5; QTcB; >60; n= 14,17,0,0,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 7; QTcB; <=60; n= 0,0,0,0,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcF; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; >60; n= 0,0,2,1,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTcB; <=60; n= 0,0,2,1,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; >60; n= 0,0,0,1,1,2 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcF <=60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; <=60; n=0,0,0,0,1,2 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 4; QTc; <=60; n= 0,0,0,1,1,2 | 2 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcF; <=60; n= 0,0,2,2,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; >60; n= 0,0,2,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB >60; n= 23,28,3,2,0,0 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 5; QTc; >60; n= 0,0,0,0,1,2 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTcB; <=60; n= 0,0,2,2,2,1 | 1 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; >60; n= 0,0,0,1,1,3 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 3; QTc; <=60; n= 0,0,0,1,1,3 | 3 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Intolerance Day 2; QTcF; >60; n= 0,0,3,2,2,1 | 0 Participants |
| Baseline EN Intolerant: Metoclopramide 10 mg | Number of Participants With Maximum Increase From Baseline in Electrocardiogram (ECG) Values | Day 1; QTcB <=60; n= 23,28,3,2,0,0 | 0 Participants |
Secondary
Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes
The total number of vomiting, regurgitation and macroaspiration episodes were categorized separately for prior to and post intolerance. Intolerance was considered as start of intolerance treatment. Only the records with non-zero counts were listed.
Time frame: up to 23 days
Population: Enrolled Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Camicinal 50 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Macroaspiration | 0 Participants |
| Camicinal 50 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Vomiting | 6 Participants |
| Camicinal 50 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Regurgitation | 1 Participants |
| Placebo | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Macroaspiration | 1 Participants |
| Placebo | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Vomiting | 7 Participants |
| Placebo | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Regurgitation | 1 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Regurgitation | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Vomiting | 0 Participants |
| Baseline EN Tolerant: Placebo/Camicinal 50 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Macroaspiration | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Regurgitation | 0 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Vomiting | 1 Participants |
| Baseline EN Tolerant: Camicinal 50 mg/ Metoclopramide 10 mg | Number of Participants With Occurrences of Vomiting, Regurgitation and Macroaspiration Episodes | Macroaspiration | 0 Participants |
Secondary
Percentage of Participants That Became Intolerant
Percentage of participants that became intolerant was calculated. Those participants who developed intolerance were assessed to characterize gastric emptying (GE). Participants who did not develop intolerance were censored at the time of the last available Gastric Residual Volume (GRV) measurement.
Time frame: Up to Day 7
Population: ITT (exposed) Population. Two participants in the camicinal group and one participant in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Camicinal 50 mg | Percentage of Participants That Became Intolerant | 15 Percentage of participants |
| Placebo | Percentage of Participants That Became Intolerant | 14 Percentage of participants |
Secondary
Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance
Time required for the delivery of 80 percent prescribed calories prior to intolerance was calculated using Kaplan-Meier estimates for time variable. Prior to intolerance was defined as prior to start of intolerance treatment. Participants who did not reach delivery of 80 percent prescribed calories were censored at the last day on which they received randomized treatment and with available nutritional data.
Time frame: Up to Day 7
Population: ITT (exposed) Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Camicinal 50 mg | Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance | 2.0 Days |
| Placebo | Time to Delivery of 80 Percent Prescribed Calories Prior to Intolerance | 1.0 Days |
Secondary
Time to Development of Feeding Intolerance
Time required for the development of feeding intolerance was calculated using Kaplan-Meier estimates for time variable. Median and quartiles were not calculable due to the small number of participants developing EN intolerance and mean and standard error of mean were presented.
Time frame: Up to Day 7
Population: ITT (exposed) Population. Two subjects in the Camicinal group and one subject in the placebo group had their last available GRV assessment done prior to first dose and are therefore excluded from this summary.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Camicinal 50 mg | Time to Development of Feeding Intolerance | 102.9 Hr | Standard Error 5.39 |
| Placebo | Time to Development of Feeding Intolerance | 108.0 Hr | Standard Error 6.26 |
Secondary
Total GRV for 24 hr Period
Total GRV for each 24 hr period up to 7 days were assessed to determine the effect of GSK962040 vs. Placebo upon the daily GRV. Intolerance was defined as start of the intolerance treatment. The total GRV for each 24hr period was the sum of all available GRV measurements during the period. The 24hr was counted using the same 24hr clock as for the collection of nutritional data.
Time frame: Up to Day 7
Population: ITT (exposed) Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 1; n= 36,34 | 37.2 mL | Standard Deviation 64.64 |
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 5; n= 19,19 | 185.2 mL | Standard Deviation 312.93 |
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 2; n= 34,32 | 118.5 mL | Standard Deviation 290.26 |
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 3; n= 29,26 | 169.7 mL | Standard Deviation 259.73 |
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 4; n= 23,22 | 131.9 mL | Standard Deviation 178.71 |
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 6; n= 15,15 | 180.0 mL | Standard Deviation 313.03 |
| Camicinal 50 mg | Total GRV for 24 hr Period | Day 7; n= 12,10 | 85.6 mL | Standard Deviation 155.67 |
| Placebo | Total GRV for 24 hr Period | Day 6; n= 15,15 | 135.7 mL | Standard Deviation 285.43 |
| Placebo | Total GRV for 24 hr Period | Day 4; n= 23,22 | 83.3 mL | Standard Deviation 106.55 |
| Placebo | Total GRV for 24 hr Period | Day 1; n= 36,34 | 92.7 mL | Standard Deviation 184.83 |
| Placebo | Total GRV for 24 hr Period | Day 5; n= 19,19 | 97.5 mL | Standard Deviation 150.45 |
| Placebo | Total GRV for 24 hr Period | Day 2; n= 34,32 | 191.6 mL | Standard Deviation 259.93 |
| Placebo | Total GRV for 24 hr Period | Day 7; n= 12,10 | 60.2 mL | Standard Deviation 45.66 |
| Placebo | Total GRV for 24 hr Period | Day 3; n= 29,26 | 143.3 mL | Standard Deviation 258.46 |