Infections, Urinary Tract
Conditions
Keywords
Gram-negative, uropathogens, complicated lower urinary tract infection, pyelonephritis
Brief summary
This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.
Interventions
DRUGGSK2251052
Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion
Prepare as per prescribing information instructions in 100 mL bag of 0.9% NaCl and administered via IV infusion
OTHERPlacebo
saline placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adult subjects least 18 years of age. N.B. Females of non-childbearing or childbearing potential may be enrolled. Females of childbearing potential must have a negative pregnancy test at study entry and must have practiced adequate contraception for at least 30 days prior to study entry. Additionally, the subject agrees to one of the following methods for avoidance of pregnancy during the entire study treatment period: * Abstinence; or, * Oral Contraceptive, either combined estrogen/progesterone or progesterone alone, PLUS an additional barrier method \[ie, condom, occlusive cap (diaphragm or cervical/vault caps) or vaginal spermicidal agent (foam/gel/film/cream/suppository)\]; or, * Injectable progesterone; or * Implants of levonorgestrel; or, * Estrogenic vaginal ring; or, * Percutaneous contraceptive patches; or * Intrauterine device (IUD) or intrauterine system (IUS) showing that failure rate is less than 1% in the IUD or IUS product label; or, * Has a male partner who is sterilized (vasectomy with documentation of azoospermia). * Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) * Females are considered to be of non-childbearing potential if they have documented tubal ligation or hysterectomy; or are postmenopausal, defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/ml and estradiol \< 40 pg/ml (\<147 pmol/L) is confirmatory\] * Subject requires hospitalisation and has clinical signs and symptoms of lower cUTI or pyelonephritis (complicated or uncomplicated) as defined below, that requires parenteral treatment only with a treatment course of a minimum of 5 days and a maximum of 14 days: * Lower cUTI - subjects must have documented fever defined as \>38°C oral, \>38.5°C tympanic or \>39°C rectal, within the last 24 hours exceptions would be: * Afebrile subjects with lower cUTI who have a white blood cell count (WBC) ≥15,000 cells/mm3 * Afebrile subjects with a lower cUTI following requiring parenteral therapy due to a specific indication e.g. before and during an operative procedure, when oral antibiotics are not indicated or in cases where the cUTI is suspected to be due to a pathogen resistant to current oral antibiotics * and at least two of the following UTI symptoms including dysuria, frequency, urgency or suprapubic pain, with the presence of a complicating factor: * Male gender; * Current bladder instrumentation or indwelling urinary catheter that has to be removed two days before the end of IV study drug administration; * Obstructive uropathy that is expected to be medically or surgically treated during the course of IV study drug administration; * Urogenital surgery within 7 days preceding administration of the first dose of study drug; * Functional or anatomical abnormality of the urogenital tract including anatomic malformations or neurogenic bladder with voiding disturbance of at least 100 mL residual urine. * Acute pyelonephritis (complicated or uncomplicated): subjects must have documented fever defined as \>38°C oral, \>38.5°C tympanic or \>39°C rectal, within the last 24 hours and flank pain or costovertebral angle tenderness (CVA). Complicating factors for pyelonephritis are the same as for complicated UTI. * Subject has pyuria (white blood cell \[WBC\] count \> 10/µL (or \>5/high-power field \[HPF\] in a conventional urinalysis) in unspun clean-catch midstream urine (MSU) or catheter urine sample or \>= 10 WBC/HPF in spun MSU or catheter urine). * Subject has Gram-negative organism(s) on direct examination of a Gram-stained specimen from unspun or spun MSU or catheter urine sample. * Subject has provided a pre-therapy urine specimen obtained within 48 hours prior to the start of therapy, which when cultured has grown at least one and not more than two Gram-negative uropathogens at \>=10\^5 CFU/mL. * A subject may be enrolled before the results of the pre-therapy urine culture is known, but the subject should be withdrawn from the study if the culture does not yield at least one but not more than two qualifying Gram-negative uropathogens at \>=10\^5 CFU/mL or if the culture yields Gram-positive uropathogens. * A subject with lower cUTI or pyelonephritis (complicated or uncomplicated) who has failed a previous antibacterial treatment regimen is eligible provided a urine specimen is positive for one and not more than two bacterial Gram-negative uropathogens at \>=10\^5 CFU/mL. Subjects who are treatment failures due to imipenem-cilastatin should not be enrolled. * QTcB or QTcF \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block *
Exclusion criteria
Subjects meeting any of the following criteria must not be enrolled in the study: * Concomitant infection requiring systemic antibacterial therapy other than study drugs at the time of randomisation. * Subject is known to have one or more of the following: * A urinary catheter that is not being removed during the study (or with an expectation that a catheter would be inserted during therapy with study drug and subsequently not removed during the study period; (intermittent straight catheterisation is acceptable) * Complete permanent obstruction of the urinary tract; * A permanent indwelling catheter or comparable instrumentation including nephrostomy that will not be removed during IV study drug administration * Suspected or confirmed prostatitis * Suspected or confirmed perinephric or intrarenal abscess * A UTI suspected or confirmed to be fungal in origin (with \>= 10\^3 fungal CFU/mL) * A UTI suspected or confirmed to be due to a Gram-positive uropathogen(s), with \>= 10\^5 Gram-positive organism CFU/mL; * A UTI known at study entry to be caused by a pathogen(s) resistant to the study antimicrobial agent; * Known ileal loops or vesico-ureteral reflux ; * Polycystic kidney disease. * Subject has an APACHE II score \>20 * Subject has known severe impairment of renal function including: a calculated creatinine clearance (CrCl) of less than 50 mL/min; requirement for peritoneal dialysis, haemodialysis, or haemofiltration; oliguria (less than 20 mL urine output per hour over 24 hours); * Subject with an intractable lower cUTI requiring more than 14 Days IV treatment. * Subjects with asymptomatic lower cUTI, such as subjects with spinal cord injury with lower cUTI who are not able to perceive symptoms due to their injury. * Subject with lower cUTI or pyelonephritis (complicated and uncomplicated) who has received any amount of a potentially therapeutic antibiotic within the 96 h before providing the baseline urine culture specimen or prior to the start of the study. * Subject has Gram-positive organism(s) on direct examination of a Gram-stained specimen of spun/unspun MSU or catheter urine. * Subject is considered unlikely to survive the 4 6 week study period or has any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure, respiratory failure or septic shock). * Subject has evidence of known or pre-existing severe hepatic disease (Child-Pugh score of B or C). * Subject has a known baseline haemoglobin less than 10 g/dL ,haematocrit less than 30% and/or a known reticulocyte count of \>5% (i.e., reticulocytes \>5% of total RBC mass) * Subject has known neutropenia or is anticipated to develop neutropenia during the course of the study (i.e., new chemotherapy subject), with absolute neutrophil count less than 1000 cells/mm3 * Subject has a known platelet count less than 75,000 cells /mm3 (subjects with platelet counts as low as 50,000 cells /mm3 are eligible if the reduction is historically stable). * Subject has an immunocompromising illness; including known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), organ (including bone marrow) transplantation, hematological malignancy, and/or immunosuppressive therapy , including high-dose corticosteroids (e.g., greater than 40 mg prednisone or equivalent per day for greater than two weeks) * Subject has participated in any investigational drug or device study within 30 days of study entry or within 5 half-lives, whichever is longer. * Subject has previously received treatment with GSK2251052. * Subject has a prior history of seizures or has a CNS abnormality predisposing them to seizures or has a lowered seizure threshold and/or is using concomitant medications with seizure potential. * Subject requires probenicid or valproic acid medications. * Subject has a history of moderate or severe hypersensitivity to beta-lactam antibiotics. * Subject is pregnant or nursing * Subject, in the opinion of the investigator may be significantly compromised by a potential drop in haemoglobin ≥2.5g/dl which is not related to the condition under study * French subjects: the French subject has participated in any study using an investigational drug during the previous 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC are presented. |
| Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | Up to 28 days post-therapy | AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit. |
| Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Up to Late Follow up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented. |
| Summary of Vital Signs- Mean Heart Rate | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented. |
| Summary of Vital Signs- Mean Respiration Rate | Up to Late Follow-up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented. |
| Summary of Vital Signs- Mean Temperature | Up to Late Follow up Visit (21 to 28 days post-IV therapy) | Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF). |
| Therapeutic Response at the Test of Cure Visit | Test of Cure Visit (5 to 9 days post-IV therapy) | The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. |
| Change From Baseline in Hematology Parameters- Hematocrit | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Hematology parameters included hematocrit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hematocrit are presented. |
| Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Hematology parameters included MCH. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCH are presented. |
| Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Hematology parameters included MCV. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCV are presented. |
| Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Hematology parameters included RBC count and reticulocytes. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in RBC count and reticulocytes are presented. |
| Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Hematology parameters included hemoglobin and MCHC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hemoglobin and MCHC are presented. |
| Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented. |
| Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented. |
| Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented. |
| Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented. |
| Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy) | Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy) | Clinical response was a combination of clinical success and clinical failure. In clinical success, participants showed no signs and symptoms of pyelonephritis and lower complicated urinary tract infection and antibiotics are not used for the same. In clinical failure, there is reappearance of signs and symptoms of and lower complicated urinary tract infection and participant required antibiotics for the same. |
| Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy) | The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. |
| Maximum Plasma Concentration (Cmax) of GSK2251052 | Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Area Under the Concentration Time Curve (AUC) of GSK2251052 | Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Time to Cmax (Tmax) of GSK2251052 | Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Cmax of GSK2251052 Using Non-intensive PK Sampling | Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| AUC of GSK2251052 Using Non-intensive PK Sampling | Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Tmax of GSK2251052 Using Non-intensive PK Sampling | Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Cmax of GSK2251052 Using Intensive PK Sampling | Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| AUC of GSK2251052 Using Intensive PK Sampling | Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Tmax of GSK2251052 Using Intensive PK Sampling | Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose | The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected. |
| Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy) | Microbiological response involved both microbiological success and microbiological failure. A reduction in the uropathogens in the urine culture and no growth on blood culture was termed as microbiological success. Increase in the uropathogens in the urine culture and pathogens identified in the blood culture or use of antibacterials other than study treatments were classified as microbiological failures. |
Countries
Canada, France, Greece, Russia, Spain, United States
Participant flow
Recruitment details
This study was conducted at eight centers in three countries (United States, Spain and Greece) from 28-June-2011 to 06-March-2012. A total of 20 participants were randomized in the study.
Pre-assignment details
It was planned to enroll approximately 210 male and female participants with lower complicated urinary tract infection (cUTI) or pyelonephritis (complicated and uncomplicated); however, due to some unexpected microbiological findings, this study was terminated early with only 20 participants enrolled.
Participants by arm
| Arm | Count |
|---|---|
| GSK2251052 750 mg Eligible participants received GSK2251052, 750 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin matching placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study. | 6 |
| GSK2251052 1500 mg Eligible participants received GSK2251052, 1500 mg, in 200 or 250 mL saline solution as IV infusion administered over 60 minutes, BID and Imipenem-cilastatin placebo solution, 100 mL, administered over 20 to 30 minutes, four times daily from Day 2 to Day 14 of the study. | 8 |
| Imipenem-Cilastatin Eligible participants received Imipenem-cilastatin 500 mg in 100 mL saline solution as IV infusion administered over 20 to 30 minutes four times daily and two doses of GSK2251052 matching placebo saline solution, 200 or 250 mL, administered over 60 minutes, BID from Day 2 to Day 14 of the study. | 6 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Ineligible: No organisms isolated | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | GSK2251052 750 mg | GSK2251052 1500 mg | Imipenem-Cilastatin | Total |
|---|---|---|---|---|
| Age, Continuous | 55.7 Years STANDARD_DEVIATION 13.6 | 50.4 Years STANDARD_DEVIATION 24.45 | 48.0 Years STANDARD_DEVIATION 17.48 | 51.3 Years STANDARD_DEVIATION 18.95 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 5 Participants | 17 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 5 / 6 | 5 / 8 | 5 / 6 |
| serious Total, serious adverse events | 1 / 6 | 2 / 8 | 0 / 6 |
Outcome results
Primary
Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)
Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 8) | -2.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Early Follow-up | -41.4 International units per Liter | Standard Deviation 158.04 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 5) | 33.2 International units per Liter | Standard Deviation 46.82 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Late Follow-up | -37.8 International units per Liter | Standard Deviation 134.8 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 5) | 11.2 International units per Liter | Standard Deviation 22.99 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : On IV therapy (Day 5) | 41.7 International units per Liter | Standard Deviation 49.61 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : On IV therapy (Day 11) | 22.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : End of IV therapy | 35.8 International units per Liter | Standard Deviation 49.96 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 11) | 2.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Test of Cure | 16.5 International units per Liter | Standard Deviation 20.67 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 8) | -10.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Early Follow-up | -1.4 International units per Liter | Standard Deviation 36.9 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Late Follow-up | -16.7 International units per Liter | Standard Deviation 54.7 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: End of IV therapy | 35.4 International units per Liter | Standard Deviation 40.46 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 11) | -11.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: End of IV therapy | 7.4 International units per Liter | Standard Deviation 26.28 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Test of Cure | 10.8 International units per Liter | Standard Deviation 23.47 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Early Follow-up | 7.4 International units per Liter | Standard Deviation 21.01 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Test of Cure | 17.5 International units per Liter | Standard Deviation 18.53 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Late Follow-up | 5.7 International units per Liter | Standard Deviation 20.64 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 3) | 5.0 International units per Liter | Standard Deviation 12.07 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 5) | 31.5 International units per Liter | Standard Deviation 57.16 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 3) | 5.7 International units per Liter | Standard Deviation 8.14 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Early Follow-up | 4.8 International units per Liter | Standard Deviation 5.97 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 11) | 2.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: End of IV therapy | 22.0 International units per Liter | Standard Deviation 34.71 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Test of Cure | 1.5 International units per Liter | Standard Deviation 9.81 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 8) | 4.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Early Follow-up | -1.2 International units per Liter | Standard Deviation 8.56 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Late Follow-up | 3.3 International units per Liter | Standard Deviation 5.99 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Late Follow-up | 3.3 International units per Liter | Standard Deviation 15.02 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : On IV therapy (Day 5) | -76.0 International units per Liter | Standard Deviation 118.58 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : On IV therapy (Day 11) | 4.0 International units per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : End of IV therapy | -36.0 International units per Liter | Standard Deviation 33.56 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 3) | 10.8 International units per Liter | Standard Deviation 26.33 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Test of Cure | -65.3 International units per Liter | Standard Deviation 129.24 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 8) | 1.5 International units per Liter | Standard Deviation 6.36 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : On IV therapy (Day 5) | -37.8 International units per Liter | Standard Deviation 46.94 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: End of IV therapy | 16.3 International units per Liter | Standard Deviation 34.62 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : End of IV therapy | -165.6 International units per Liter | Standard Deviation 407.7 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: End of IV therapy | 18.6 International units per Liter | Standard Deviation 21.35 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 8) | 2.0 International units per Liter | Standard Deviation 0 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Test of Cure | -156.4 International units per Liter | Standard Deviation 420 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 3) | 14.3 International units per Liter | Standard Deviation 30.12 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Test of Cure | 6.9 International units per Liter | Standard Deviation 15.04 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Early Follow-up | -218.2 International units per Liter | Standard Deviation 495.53 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 5) | 4.8 International units per Liter | Standard Deviation 8.85 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Test of Cure | -2.3 International units per Liter | Standard Deviation 4.54 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Late Follow-up | -168.8 International units per Liter | Standard Deviation 448.9 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Early Follow-up | 1.2 International units per Liter | Standard Deviation 23.73 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Late Follow-up | -3.3 International units per Liter | Standard Deviation 10.07 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : On IV therapy (Day 5) | 6.5 International units per Liter | Standard Deviation 8.27 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 5) | 4.0 International units per Liter | Standard Deviation 27.14 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Late Follow-up | -0.3 International units per Liter | Standard Deviation 4.32 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Late Follow-up | 2.3 International units per Liter | Standard Deviation 13.81 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : End of IV therapy | 28.9 International units per Liter | Standard Deviation 39.88 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Test of Cure | 7.3 International units per Liter | Standard Deviation 10.34 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: End of IV therapy | 13.1 International units per Liter | Standard Deviation 15.08 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Test of Cure | 23.3 International units per Liter | Standard Deviation 24.69 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 3) | 4.1 International units per Liter | Standard Deviation 12.58 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 3) | 10.4 International units per Liter | Standard Deviation 21.53 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Early Follow-up | 8.3 International units per Liter | Standard Deviation 13.54 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 8) | 21.5 International units per Liter | Standard Deviation 12.02 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Early Follow-up | 1.0 International units per Liter | Standard Deviation 5.33 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Late Follow-up | 1.3 International units per Liter | Standard Deviation 9.58 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 5) | 6.3 International units per Liter | Standard Deviation 13.38 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Early Follow-up | -4.8 International units per Liter | Standard Deviation 10.34 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 5) | 20.0 International units per Liter | Standard Deviation 34.66 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 3) | 12.8 International units per Liter | Standard Deviation 11.19 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 5) | 13.3 International units per Liter | Standard Deviation 17.9 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: On IV therapy (Day 8) | -3.0 International units per Liter | — |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: End of IV therapy | 21.3 International units per Liter | Standard Deviation 29.3 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Test of Cure | 7.0 International units per Liter | Standard Deviation 10.12 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Early Follow-up | 5.8 International units per Liter | Standard Deviation 7.4 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALT: Late Follow-up | 4.2 International units per Liter | Standard Deviation 5.5 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 3) | 13.2 International units per Liter | Standard Deviation 28.28 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 5) | 17.7 International units per Liter | Standard Deviation 35.5 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: On IV therapy (Day 8) | -10.0 International units per Liter | — |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: End of IV therapy | 10.2 International units per Liter | Standard Deviation 22.6 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Test of Cure | 14.8 International units per Liter | Standard Deviation 17.01 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Early Follow-up | 8.2 International units per Liter | Standard Deviation 12.01 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | ALP: Late Follow-up | 3.6 International units per Liter | Standard Deviation 13.13 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 3) | 19.2 International units per Liter | Standard Deviation 16.04 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: On IV therapy (Day 8) | 2.0 International units per Liter | — |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: End of IV therapy | 15.7 International units per Liter | Standard Deviation 23.34 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Test of Cure | -1.4 International units per Liter | Standard Deviation 6.5 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Early Follow-up | 1.2 International units per Liter | Standard Deviation 6.76 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | AST: Late Follow-up | 3.4 International units per Liter | Standard Deviation 2.88 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : On IV therapy (Day 5) | -26.0 International units per Liter | Standard Deviation 18.33 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : End of IV therapy | -23.7 International units per Liter | Standard Deviation 18.33 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Test of Cure | 18.4 International units per Liter | Standard Deviation 18.8 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Early Follow-up | -6.0 International units per Liter | Standard Deviation 30.12 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | Creatine kinase : Late Follow-up | 0.2 International units per Liter | Standard Deviation 41.05 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : On IV therapy (Day 5) | 24.0 International units per Liter | Standard Deviation 35.68 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : End of IV therapy | 14.0 International units per Liter | Standard Deviation 20.27 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Test of Cure | 3.6 International units per Liter | Standard Deviation 8.76 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Early Follow-up | -0.8 International units per Liter | Standard Deviation 12.15 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT) | GGT : Late Follow-up | -3.8 International units per Liter | Standard Deviation 12.03 |
Primary
Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein
Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population which comprised of all participants who received at least one dose of study medication. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Late Follow-up | 7.3 Gram per Liter | Standard Deviation 4.93 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: End of IV therapy | 1.0 Gram per Liter | Standard Deviation 4.69 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: On IV therapy (Day 11) | -5.0 Gram per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: On IV therapy (Day 5) | 0.0 Gram per Liter | Standard Deviation 8.17 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: On IV therapy (Day 5) | -0.5 Gram per Liter | Standard Deviation 4.85 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Early Follow-up | 9.4 Gram per Liter | Standard Deviation 5.13 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Test of Cure | 5.7 Gram per Liter | Standard Deviation 3.67 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Late Follow-up | 8.2 Gram per Liter | Standard Deviation 4.92 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Test of Cure | 5.8 Gram per Liter | Standard Deviation 7.68 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Early Follow-up | 8.2 Gram per Liter | Standard Deviation 2.77 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: On IV therapy (Day 11) | 2.0 Gram per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: End of IV therapy | -0.4 Gram per Liter | Standard Deviation 9.76 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: On IV therapy (Day 5) | -5.0 Gram per Liter | Standard Deviation 9.09 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: On IV therapy (Day 5) | -3.8 Gram per Liter | Standard Deviation 7.09 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Test of Cure | 1.7 Gram per Liter | Standard Deviation 5.79 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Early Follow-up | 3.5 Gram per Liter | Standard Deviation 3.39 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Late Follow-up | 3.5 Gram per Liter | Standard Deviation 4.59 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: End of IV therapy | -3.3 Gram per Liter | Standard Deviation 10.14 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Test of Cure | 2.1 Gram per Liter | Standard Deviation 6.89 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Early Follow-up | 5.3 Gram per Liter | Standard Deviation 3.27 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: End of IV therapy | -2.1 Gram per Liter | Standard Deviation 7.38 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Late Follow-up | 5.3 Gram per Liter | Standard Deviation 6.28 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Test of Cure | 2.6 Gram per Liter | Standard Deviation 2.61 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: On IV therapy (Day 5) | -0.3 Gram per Liter | Standard Deviation 3.06 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Test of Cure | 6.4 Gram per Liter | Standard Deviation 3.29 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: End of IV therapy | 0.8 Gram per Liter | Standard Deviation 3.31 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Late Follow-up | 4.8 Gram per Liter | Standard Deviation 5.4 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: On IV therapy (Day 5) | 1.0 Gram per Liter | Standard Deviation 6.24 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Late Follow-up | 3.2 Gram per Liter | Standard Deviation 3.77 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Albumin: Early Follow-up | 3.4 Gram per Liter | Standard Deviation 3.65 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: Early Follow-up | 6.4 Gram per Liter | Standard Deviation 4.98 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein | Total protein: End of IV therapy | 3.0 Gram per Liter | Standard Deviation 6.69 |
Primary
Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: On IV therapy (Day 11) | 0.030 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: End of IV therapy | -0.020 Millimole per Liter | Standard Deviation 0.2411 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Test of Cure | 0.235 Millimole per Liter | Standard Deviation 0.2627 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: On IV therapy (Day 5) | -1.7 Millimole per Liter | Standard Deviation 3.01 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: On IV therapy (Day 11) | -3.0 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: End of IV therapy | -2.4 Millimole per Liter | Standard Deviation 2.07 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Test of Cure | -0.8 Millimole per Liter | Standard Deviation 1.72 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Early Follow-up | 0.0 Millimole per Liter | Standard Deviation 3.81 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Late Follow-up | 0.7 Millimole per Liter | Standard Deviation 2.34 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: On IV therapy (Day 5) | 1.2 Millimole per Liter | Standard Deviation 4.07 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: On IV therapy (Day 11) | 4.0 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: End of IV therapy | 1.0 Millimole per Liter | Standard Deviation 3.74 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Test of Cure | 0.5 Millimole per Liter | Standard Deviation 3.94 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Early Follow-up | 0.6 Millimole per Liter | Standard Deviation 4.72 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Late Follow-up | 0.3 Millimole per Liter | Standard Deviation 4.18 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: On IV therapy (Day 5) | 0.42 Millimole per Liter | Standard Deviation 1.993 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: On IV therapy (Day 11) | 1.50 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: End of IV therapy | -1.06 Millimole per Liter | Standard Deviation 1.372 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Test of Cure | -0.35 Millimole per Liter | Standard Deviation 1.649 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Early Follow-up | -0.80 Millimole per Liter | Standard Deviation 1.158 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Late Follow-up | -0.45 Millimole per Liter | Standard Deviation 1.106 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: On IV therapy (Day 5) | 0.52 Millimole per Liter | Standard Deviation 0.662 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: On IV therapy (Day 11) | 0.00 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: End of IV therapy | 0.46 Millimole per Liter | Standard Deviation 0.623 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Test of Cure | 0.78 Millimole per Liter | Standard Deviation 0.739 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Early Follow-up | 0.40 Millimole per Liter | Standard Deviation 0.725 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Late Follow-up | 0.28 Millimole per Liter | Standard Deviation 0.471 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: On IV therapy (Day 5) | 1.2 Millimole per Liter | Standard Deviation 2.23 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: On IV therapy (Day 11) | 4.0 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: End of IV therapy | 0.4 Millimole per Liter | Standard Deviation 2.79 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Test of Cure | 1.8 Millimole per Liter | Standard Deviation 1.33 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Early Follow-up | 1.8 Millimole per Liter | Standard Deviation 3.27 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Late Follow-up | 1.2 Millimole per Liter | Standard Deviation 3.54 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: On IV therapy (Day 5) | -0.98 Millimole per Liter | Standard Deviation 2.024 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: On IV therapy (Day 11) | -2.50 Millimole per Liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: End of IV therapy | -0.30 Millimole per Liter | Standard Deviation 2.633 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Test of Cure | -0.38 Millimole per Liter | Standard Deviation 1.184 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Early Follow-up | -0.64 Millimole per Liter | Standard Deviation 1.305 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Late Follow-up | -0.30 Millimole per Liter | Standard Deviation 0.716 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: On IV therapy (Day 5) | 0.082 Millimole per Liter | Standard Deviation 0.1664 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Early Follow-up | 0.276 Millimole per Liter | Standard Deviation 0.1383 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Late Follow-up | 0.243 Millimole per Liter | Standard Deviation 0.0922 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Late Follow-up | 0.115 Millimole per Liter | Standard Deviation 0.1027 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Early Follow-up | 0.120 Millimole per Liter | Standard Deviation 0.0919 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Test of Cure | -0.73 Millimole per Liter | Standard Deviation 1.456 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: On IV therapy (Day 5) | 0.0 Millimole per Liter | Standard Deviation 2.83 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: End of IV therapy | 0.24 Millimole per Liter | Standard Deviation 0.509 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: On IV therapy (Day 5) | 0.3 Millimole per Liter | Standard Deviation 2.75 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: End of IV therapy | 1.09 Millimole per Liter | Standard Deviation 1.542 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: End of IV therapy | 0.6 Millimole per Liter | Standard Deviation 2.3 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: End of IV therapy | -1.13 Millimole per Liter | Standard Deviation 1.367 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Test of Cure | 0.40 Millimole per Liter | Standard Deviation 0.526 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Test of Cure | 2.7 Millimole per Liter | Standard Deviation 1.8 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: On IV therapy (Day 5) | -0.45 Millimole per Liter | Standard Deviation 1.515 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: On IV therapy (Day 5) | -0.112 Millimole per Liter | Standard Deviation 0.217 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Early Follow-up | 0.3 Millimole per Liter | Standard Deviation 1.63 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Late Follow-up | 0.58 Millimole per Liter | Standard Deviation 1.703 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: End of IV therapy | 1.7 Millimole per Liter | Standard Deviation 3.15 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Late Follow-up | 1.8 Millimole per Liter | Standard Deviation 2.71 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Early Follow-up | 0.50 Millimole per Liter | Standard Deviation 0.4 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Test of Cure | -0.11 Millimole per Liter | Standard Deviation 1.173 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: On IV therapy (Day 5) | 1.8 Millimole per Liter | Standard Deviation 3.5 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Late Follow-up | -1.2 Millimole per Liter | Standard Deviation 4.36 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Early Follow-up | 0.20 Millimole per Liter | Standard Deviation 2.262 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Test of Cure | 1.3 Millimole per Liter | Standard Deviation 3.4 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: End of IV therapy | 3.0 Millimole per Liter | Standard Deviation 3.83 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Late Follow-up | 0.53 Millimole per Liter | Standard Deviation 0.547 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: End of IV therapy | 0.071 Millimole per Liter | Standard Deviation 0.1964 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Test of Cure | 1.0 Millimole per Liter | Standard Deviation 3.83 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: On IV therapy (Day 5) | -0.05 Millimole per Liter | Standard Deviation 0.645 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Late Follow-up | -0.33 Millimole per Liter | Standard Deviation 1.199 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Early Follow-up | 0.5 Millimole per Liter | Standard Deviation 4.51 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Test of Cure | 0.096 Millimole per Liter | Standard Deviation 0.2057 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Early Follow-up | -0.5 Millimole per Liter | Standard Deviation 3.45 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Late Follow-up | -0.5 Millimole per Liter | Standard Deviation 3.02 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Early Follow-up | 0.07 Millimole per Liter | Standard Deviation 1.316 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: On IV therapy (Day 5) | 2.25 Millimole per Liter | Standard Deviation 1.7 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Early Follow-up | 1.0 Millimole per Liter | Standard Deviation 1.58 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: On IV therapy (Day 5) | -2.00 Millimole per Liter | Standard Deviation 2.685 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Early Follow-up | 0.142 Millimole per Liter | Standard Deviation 0.1232 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: End of IV therapy | -0.68 Millimole per Liter | Standard Deviation 2.741 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Late Follow-up | 2.0 Millimole per Liter | Standard Deviation 2.65 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Test of Cure | -0.24 Millimole per Liter | Standard Deviation 2.261 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Early Follow-up | -0.78 Millimole per Liter | Standard Deviation 1.949 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Glucose: Late Follow-up | -0.56 Millimole per Liter | Standard Deviation 2.395 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: On IV therapy (Day 5) | -0.97 Millimole per Liter | Standard Deviation 0.874 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: On IV therapy (Day 5) | 0.37 Millimole per Liter | Standard Deviation 0.666 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Late Follow-up | -0.12 Millimole per Liter | Standard Deviation 1.932 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: End of IV therapy | 0.48 Millimole per Liter | Standard Deviation 0.407 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Test of Cure | 0.44 Millimole per Liter | Standard Deviation 0.351 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: End of IV therapy | -0.57 Millimole per Liter | Standard Deviation 1.046 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Early Follow-up | 0.42 Millimole per Liter | Standard Deviation 0.327 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: On IV therapy (Day 5) | 0.060 Millimole per Liter | Standard Deviation 0.1229 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: End of IV therapy | 0.078 Millimole per Liter | Standard Deviation 0.093 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Potassium: Late Follow-up | 0.40 Millimole per Liter | Standard Deviation 0.495 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Test of Cure | 0.128 Millimole per Liter | Standard Deviation 0.1114 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Calcium: Late Follow-up | 0.110 Millimole per Liter | Standard Deviation 0.1538 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: On IV therapy (Day 5) | -2.0 Millimole per Liter | Standard Deviation 0 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: On IV therapy (Day 5) | 2.3 Millimole per Liter | Standard Deviation 2.52 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: End of IV therapy | -0.3 Millimole per Liter | Standard Deviation 2.88 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Test of Cure | -0.38 Millimole per Liter | Standard Deviation 1.033 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Test of Cure | 1.4 Millimole per Liter | Standard Deviation 4.28 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Early Follow-up | -0.4 Millimole per Liter | Standard Deviation 4.72 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | C02 content/Bicarbonate: Late Follow-up | 1.2 Millimole per Liter | Standard Deviation 4.97 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: End of IV therapy | -0.8 Millimole per Liter | Standard Deviation 2.14 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: On IV therapy (Day 5) | 3.7 Millimole per Liter | Standard Deviation 1.15 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: End of IV therapy | -0.2 Millimole per Liter | Standard Deviation 2.32 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Sodium: Test of Cure | 1.0 Millimole per Liter | Standard Deviation 1.73 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Test of Cure | 0.2 Millimole per Liter | Standard Deviation 2.28 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Urea/BUN: Early Follow-up | -0.34 Millimole per Liter | Standard Deviation 0.853 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Early Follow-up | 0.0 Millimole per Liter | Standard Deviation 2.35 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN) | Chloride: Late Follow-up | 2.2 Millimole per Liter | Standard Deviation 0.84 |
Primary
Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)
Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Test of Cure | 2.0 Milliliter per minute |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Late Follow-up | 25.0 Milliliter per minute |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Early Follow-up | 1.0 Milliliter per minute |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Late Follow-up | 21.0 Milliliter per minute |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Early Follow-up | 21.0 Milliliter per minute |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: On IV therapy (Day 5) | 18.0 Milliliter per minute |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Test of Cure | 13.0 Milliliter per minute |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Test of Cure | 56.0 Milliliter per minute |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE) | CCE: Early Follow-up | 60.0 Milliliter per minute |
Primary
Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin
Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Late Follow-up | 4.43 Micromole per liter | Standard Deviation 6.96 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 11) | -1.0 Micromole per liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: End of IV therapy | -8.2 Micromole per liter | Standard Deviation 11.37 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Early Follow-up | -6.2 Micromole per liter | Standard Deviation 8.29 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Test of Cure | -7.7 Micromole per liter | Standard Deviation 9.14 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Late Follow-up | -5.2 Micromole per liter | Standard Deviation 8.73 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 5) | -7.0 Micromole per liter | Standard Deviation 10.18 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: On IV therapy (Day 5) | -4.20 Micromole per liter | Standard Deviation 10.347 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 8) | -5.0 Micromole per liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: On IV therapy (Day 11) | -1.50 Micromole per liter | — |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: End of IV therapy | -0.24 Micromole per liter | Standard Deviation 13.616 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Test of Cure | -2.17 Micromole per liter | Standard Deviation 7.238 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Early Follow-up | -3.90 Micromole per liter | Standard Deviation 6.134 |
| GSK2251052 750 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 3) | -7.5 Micromole per liter | Standard Deviation 10.73 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Late Follow-up | -5.22 Micromole per liter | Standard Deviation 10.76 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Test of Cure | -4.7 Micromole per liter | Standard Deviation 5 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Early Follow-up | 2.88 Micromole per liter | Standard Deviation 14.662 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 3) | -4.9 Micromole per liter | Standard Deviation 4.45 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: On IV therapy (Day 5) | -5.78 Micromole per liter | Standard Deviation 13.336 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Test of Cure | -9.66 Micromole per liter | Standard Deviation 11.743 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 5) | -3.5 Micromole per liter | Standard Deviation 5.57 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: End of IV therapy | -5.6 Micromole per liter | Standard Deviation 0.71 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Early Follow-up | -4.5 Micromole per liter | Standard Deviation 3.39 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: End of IV therapy | -11.26 Micromole per liter | Standard Deviation 12.634 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 8) | -4.5 Micromole per liter | Standard Deviation 0.71 |
| GSK2251052 1500 mg | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Late Follow-up | -4.8 Micromole per liter | Standard Deviation 4.12 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Late Follow-up | -5.0 Micromole per liter | Standard Deviation 4.8 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 5) | -7.3 Micromole per liter | Standard Deviation 8.5 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 8) | -1.0 Micromole per liter | — |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Early Follow-up | -6.0 Micromole per liter | Standard Deviation 7.04 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: On IV therapy (Day 5) | -11.97 Micromole per liter | Standard Deviation 10.279 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: End of IV therapy | -8.70 Micromole per liter | Standard Deviation 9.426 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Test of Cure | -8.54 Micromole per liter | Standard Deviation 9.816 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Early Follow-up | -4.56 Micromole per liter | Standard Deviation 11.138 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Creatinine: Late Follow-up | -5.22 Micromole per liter | Standard Deviation 11.228 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: End of IV therapy | -5.5 Micromole per liter | Standard Deviation 6.16 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: Test of Cure | -6.4 Micromole per liter | Standard Deviation 7.64 |
| Imipenem-Cilastatin | Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin | Total bilirubin: On IV therapy (Day 3) | -7.2 Micromole per liter | Standard Deviation 6.42 |
Primary
Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)
Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Total neutrophils: End of IV therapy | -8.178 Gigacells per Liter | Standard Deviation 3.6642 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Lymphocytes: Late Follow-up | 0.687 Gigacells per Liter | Standard Deviation 1.5191 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Eosinophils: End of IV therapy | 0.274 Gigacells per Liter | Standard Deviation 0.1389 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Platelet count: Late Follow-up | 48.8 Gigacells per Liter | Standard Deviation 129.1 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Monocytes: End of IV therapy | -0.188 Gigacells per Liter | Standard Deviation 0.3739 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Basophils: Late Follow-up | 0.022 Gigacells per Liter | Standard Deviation 0.0147 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Platelet count: End of IV therapy | 141.0 Gigacells per Liter | Standard Deviation 171.58 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Monocytes: Late Follow-up | -0.380 Gigacells per Liter | Standard Deviation 0.4553 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Total neutrophils: Late Follow-up | -6.765 Gigacells per Liter | Standard Deviation 4.0488 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Eosinophils: Late Follow-up | 0.093 Gigacells per Liter | Standard Deviation 0.1488 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | WBC count: Late Follow-up | -6.33 Gigacells per Liter | Standard Deviation 4.918 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Basophils: End of IV therapy | 0.028 Gigacells per Liter | Standard Deviation 0.0084 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Lymphocytes: End of IV therapy | 0.580 Gigacells per Liter | Standard Deviation 1.2076 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | WBC count: End of IV therapy | -7.48 Gigacells per Liter | Standard Deviation 4.242 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Total neutrophils: End of IV therapy | -6.695 Gigacells per Liter | Standard Deviation 4.6214 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Basophils: End of IV therapy | 0.018 Gigacells per Liter | Standard Deviation 0.0116 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Basophils: Late Follow-up | 0.020 Gigacells per Liter | Standard Deviation 0.0163 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Eosinophils: End of IV therapy | 0.096 Gigacells per Liter | Standard Deviation 0.098 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Eosinophils: Late Follow-up | 0.067 Gigacells per Liter | Standard Deviation 0.0966 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Lymphocytes: End of IV therapy | 0.514 Gigacells per Liter | Standard Deviation 0.3816 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Lymphocytes: Late Follow-up | 0.774 Gigacells per Liter | Standard Deviation 0.4808 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Monocytes: End of IV therapy | -0.256 Gigacells per Liter | Standard Deviation 0.2015 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Monocytes: Late Follow-up | -0.230 Gigacells per Liter | Standard Deviation 0.3902 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Platelet count: End of IV therapy | 83.2 Gigacells per Liter | Standard Deviation 139.06 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Platelet count: Late Follow-up | 45.4 Gigacells per Liter | Standard Deviation 34.93 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Total neutrophils: Late Follow-up | -7.737 Gigacells per Liter | Standard Deviation 6.3494 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | WBC count: End of IV therapy | -6.30 Gigacells per Liter | Standard Deviation 4.607 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | WBC count: Late Follow-up | -7.11 Gigacells per Liter | Standard Deviation 6.207 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | WBC count: End of IV therapy | -4.36 Gigacells per Liter | Standard Deviation 6.696 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Platelet count: Late Follow-up | 39.8 Gigacells per Liter | Standard Deviation 35.81 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Lymphocytes: End of IV therapy | 0.596 Gigacells per Liter | Standard Deviation 0.514 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Eosinophils: Late Follow-up | 0.086 Gigacells per Liter | Standard Deviation 0.0385 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Total neutrophils: End of IV therapy | -4.656 Gigacells per Liter | Standard Deviation 6.6652 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Eosinophils: End of IV therapy | 0.090 Gigacells per Liter | Standard Deviation 0.0682 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Basophils: End of IV therapy | 0.014 Gigacells per Liter | Standard Deviation 0.0182 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Total neutrophils: Late Follow-up | -7.902 Gigacells per Liter | Standard Deviation 8.1795 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Basophils: Late Follow-up | 0.016 Gigacells per Liter | Standard Deviation 0.0114 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Monocytes: Late Follow-up | -0.186 Gigacells per Liter | Standard Deviation 0.2103 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Monocytes: End of IV therapy | -0.442 Gigacells per Liter | Standard Deviation 0.3841 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | WBC count: Late Follow-up | -7.54 Gigacells per Liter | Standard Deviation 8.486 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Platelet count: End of IV therapy | 105.4 Gigacells per Liter | Standard Deviation 92.2 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC) | Lymphocytes: Late Follow-up | 0.436 Gigacells per Liter | Standard Deviation 0.7578 |
Primary
Change From Baseline in Hematology Parameters- Hematocrit
Hematology parameters included hematocrit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hematocrit are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Hematocrit | End of IV therapy | -0.0140 Fraction | Standard Deviation 0.06893 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Hematocrit | Late Follow-up | 0.0373 Fraction | Standard Deviation 0.03079 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Hematocrit | End of IV therapy | -0.0155 Fraction | Standard Deviation 0.0693 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Hematocrit | Late Follow-up | -0.0007 Fraction | Standard Deviation 0.03322 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Hematocrit | End of IV therapy | -0.0120 Fraction | Standard Deviation 0.02993 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Hematocrit | Late Follow-up | -0.0038 Fraction | Standard Deviation 0.01669 |
Primary
Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Hematology parameters included hemoglobin and MCHC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hemoglobin and MCHC are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin: End of IV therapy | -3.0 Gram per Liter | Standard Deviation 22.77 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin: Late Follow-up | 11.0 Gram per Liter | Standard Deviation 7.24 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC: End of IV therapy | 4.0 Gram per Liter | Standard Deviation 3.81 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC: Late Follow-up | -3.0 Gram per Liter | Standard Deviation 8.44 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC: Late Follow-up | -5.0 Gram per Liter | Standard Deviation 5.94 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC: End of IV therapy | -1.8 Gram per Liter | Standard Deviation 6.5 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin: End of IV therapy | -5.5 Gram per Liter | Standard Deviation 21.36 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin: Late Follow-up | -2.1 Gram per Liter | Standard Deviation 9.67 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin: End of IV therapy | -2.5 Gram per Liter | Standard Deviation 8.17 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin: Late Follow-up | -0.6 Gram per Liter | Standard Deviation 4.16 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC: Late Follow-up | 1.8 Gram per Liter | Standard Deviation 8.29 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC: End of IV therapy | 4.2 Gram per Liter | Standard Deviation 6.74 |
Primary
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
Hematology parameters included MCH. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCH are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | End of IV therapy | -0.60 Picograms | Standard Deviation 0.748 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Late Follow-up | -0.85 Picograms | Standard Deviation 0.657 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | End of IV therapy | -0.60 Picograms | Standard Deviation 0.668 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Late Follow-up | -0.89 Picograms | Standard Deviation 0.573 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | End of IV therapy | -0.07 Picograms | Standard Deviation 0.628 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH) | Late Follow-up | -0.14 Picograms | Standard Deviation 0.472 |
Primary
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
Hematology parameters included MCV. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCV are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | End of IV therapy | -3.0 Femtoliters | Standard Deviation 2.45 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Late Follow-up | -2.2 Femtoliters | Standard Deviation 0.98 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Late Follow-up | -1.3 Femtoliters | Standard Deviation 2.75 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | End of IV therapy | -1.3 Femtoliters | Standard Deviation 1.98 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | End of IV therapy | -1.0 Femtoliters | Standard Deviation 0.89 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV) | Late Follow-up | -0.8 Femtoliters | Standard Deviation 1.79 |
Primary
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes
Hematology parameters included RBC count and reticulocytes. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in RBC count and reticulocytes are presented.
Time frame: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | RBC: End of IV therapy | -0.10 Trillion cells per liter | Standard Deviation 0.689 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | RBC: Late Follow-up | 0.52 Trillion cells per liter | Standard Deviation 0.366 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Reticulocytes: End of IV therapy | -0.0331 Trillion cells per liter | Standard Deviation 0.04544 |
| GSK2251052 750 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Reticulocytes: Late Follow-up | -0.0466 Trillion cells per liter | Standard Deviation 0.09881 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Reticulocytes: Late Follow-up | -0.0092 Trillion cells per liter | Standard Deviation 0.03267 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | RBC: End of IV therapy | -0.10 Trillion cells per liter | Standard Deviation 0.707 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Reticulocytes: End of IV therapy | -0.0312 Trillion cells per liter | Standard Deviation 0.02489 |
| GSK2251052 1500 mg | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | RBC: Late Follow-up | 0.07 Trillion cells per liter | Standard Deviation 0.236 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Reticulocytes: Late Follow-up | 0.0080 Trillion cells per liter | Standard Deviation 0.02577 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | RBC: Late Follow-up | 0.02 Trillion cells per liter | Standard Deviation 0.228 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | Reticulocytes: End of IV therapy | -0.0072 Trillion cells per liter | Standard Deviation 0.02295 |
| Imipenem-Cilastatin | Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes | RBC: End of IV therapy | -0.08 Trillion cells per liter | Standard Deviation 0.36 |
Primary
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit.
Time frame: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 1 | 0 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 2 | 2 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 3 | 1 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Post-dose | 1 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 4 (on IV treatment): Pre-dose | 2 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 4 (on IV treatment): Post-dose | 3 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Early Follow-up | 0 Participants |
| GSK2251052 750 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Withdrawal | 0 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 3 | 2 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Early Follow-up | 3 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Post-dose | 5 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 4 (on IV treatment): Pre-dose | 4 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 4 (on IV treatment): Post-dose | 3 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 1 | 4 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 2 | 4 Participants |
| GSK2251052 1500 mg | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Withdrawal | 0 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 3 | 3 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 2 | 2 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Pre-dose 1 | 2 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 1: Post-dose | 3 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Early Follow-up | 2 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 4 (on IV treatment): Post-dose | 2 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Day 4 (on IV treatment): Pre-dose | 2 Participants |
| Imipenem-Cilastatin | Number of Participants With Abnormal Electrocardiogram (ECG) Findings | Withdrawal | 0 Participants |
Primary
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Time frame: Up to 28 days post-therapy
Population: Safety Population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2251052 750 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 5 Participants |
| GSK2251052 750 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 1 Participants |
| GSK2251052 1500 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 2 Participants |
| GSK2251052 1500 mg | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 6 Participants |
| Imipenem-Cilastatin | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | AE | 5 Participants |
| Imipenem-Cilastatin | Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) | SAE | 0 Participants |
Primary
Summary of Vital Signs- Mean Heart Rate
Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented.
Time frame: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 7) | 81.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | Late Follow-up | 76.8 Beats per minute | Standard Deviation 13.06 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 13) | 90.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 8) | 88.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | Early Follow-up | 72.5 Beats per minute | Standard Deviation 11.57 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 12) | 84.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 9) | 84.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 2) | 78.2 Beats per minute | Standard Deviation 12.8 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 11) | 100.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 10) | 91.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 3) | 77.8 Beats per minute | Standard Deviation 4.92 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | Test of Cure | 74.5 Beats per minute | Standard Deviation 11.86 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 5) | 72.3 Beats per minute | Standard Deviation 13.52 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 4) | 78.5 Beats per minute | Standard Deviation 11.45 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | End of IV therapy | 72.8 Beats per minute | Standard Deviation 11.82 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 6) | 89.0 Beats per minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | Baseline (Day 1) | 85.8 Beats per minute | Standard Deviation 10.63 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 14) | 92.0 Beats per minute | — |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | End of IV therapy | 82.8 Beats per minute | Standard Deviation 8.91 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 4) | 81.0 Beats per minute | Standard Deviation 10.43 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 3) | 80.6 Beats per minute | Standard Deviation 14.79 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | Baseline (Day 1) | 99.3 Beats per minute | Standard Deviation 13.78 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 2) | 83.0 Beats per minute | Standard Deviation 18.97 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 5) | 80.3 Beats per minute | Standard Deviation 10.55 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 6) | 92.0 Beats per minute | Standard Deviation 16.97 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 7) | 88.5 Beats per minute | Standard Deviation 16.26 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 8) | 87.5 Beats per minute | Standard Deviation 6.36 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 9) | 80.0 Beats per minute | — |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | Test of Cure | 73.6 Beats per minute | Standard Deviation 11.94 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | Early Follow-up | 74.0 Beats per minute | Standard Deviation 14.99 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Heart Rate | Late Follow-up | 71.8 Beats per minute | Standard Deviation 11.11 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 7) | 78.3 Beats per minute | Standard Deviation 9.07 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 6) | 74.8 Beats per minute | Standard Deviation 6.7 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 5) | 68.2 Beats per minute | Standard Deviation 11.45 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 3) | 81.4 Beats per minute | Standard Deviation 9.4 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | End of IV therapy | 71.0 Beats per minute | Standard Deviation 7.32 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 4) | 73.6 Beats per minute | Standard Deviation 12.1 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 2) | 81.5 Beats per minute | Standard Deviation 4.23 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | Test of Cure | 74.6 Beats per minute | Standard Deviation 15.34 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | Baseline (Day 1) | 87.7 Beats per minute | Standard Deviation 11.78 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | Late Follow-up | 78.2 Beats per minute | Standard Deviation 11.19 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | Early Follow-up | 65.8 Beats per minute | Standard Deviation 8.9 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 10) | 86.0 Beats per minute | — |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 9) | 85.0 Beats per minute | — |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Heart Rate | On IV therapy (Day 8) | 82.0 Beats per minute | — |
Primary
Summary of Vital Signs- Mean Respiration Rate
Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented.
Time frame: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 7) | 16.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 2) | 15.0 Breaths/minute | Standard Deviation 1.67 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 13) | 14.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 8) | 16.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | Early Follow-up | 15.3 Breaths/minute | Standard Deviation 1.97 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 12) | 16.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 9) | 14.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 4) | 15.5 Breaths/minute | Standard Deviation 0.84 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 11) | 15.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 10) | 17.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | Baseline (Day 1) | 17.3 Breaths/minute | Standard Deviation 2.94 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | Test of Cure | 14.0 Breaths/minute | Standard Deviation 1.79 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 5) | 14.5 Breaths/minute | Standard Deviation 1.52 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | Late Follow-up | 13.4 Breaths/minute | Standard Deviation 1.95 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | End of IV therapy | 16.0 Breaths/minute | Standard Deviation 2.45 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 6) | 16.0 Breaths/minute | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 3) | 14.2 Breaths/minute | Standard Deviation 1.33 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 14) | 14.0 Breaths/minute | — |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | Early Follow-up | 15.9 Breaths/minute | Standard Deviation 3.52 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | Baseline (Day 1) | 19.6 Breaths/minute | Standard Deviation 3.85 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 2) | 18.1 Breaths/minute | Standard Deviation 3.68 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 3) | 16.6 Breaths/minute | Standard Deviation 3.62 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 4) | 17.3 Breaths/minute | Standard Deviation 3.99 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 5) | 16.6 Breaths/minute | Standard Deviation 3.46 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 6) | 17.0 Breaths/minute | Standard Deviation 4.24 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 7) | 16.5 Breaths/minute | Standard Deviation 3.54 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 8) | 15.0 Breaths/minute | Standard Deviation 1.41 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 9) | 16.0 Breaths/minute | — |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | End of IV therapy | 15.8 Breaths/minute | Standard Deviation 2.96 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | Test of Cure | 15.5 Breaths/minute | Standard Deviation 3.42 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Respiration Rate | Late Follow-up | 16.0 Breaths/minute | Standard Deviation 2.78 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 7) | 17.3 Breaths/minute | Standard Deviation 4.16 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 6) | 16.0 Breaths/minute | Standard Deviation 4.32 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 5) | 18.8 Breaths/minute | Standard Deviation 3.59 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | Baseline (Day 1) | 17.3 Breaths/minute | Standard Deviation 3.27 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | End of IV therapy | 16.4 Breaths/minute | Standard Deviation 2.19 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 4) | 17.8 Breaths/minute | Standard Deviation 4.35 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | Late Follow-up | 16.6 Breaths/minute | Standard Deviation 3.71 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | Test of Cure | 18.2 Breaths/minute | Standard Deviation 4.15 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 3) | 16.8 Breaths/minute | Standard Deviation 4.27 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | Early Follow-up | 16.4 Breaths/minute | Standard Deviation 3.21 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 2) | 16.8 Breaths/minute | Standard Deviation 3.03 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 10) | 20.0 Breaths/minute | — |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 9) | 22.0 Breaths/minute | — |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Respiration Rate | On IV therapy (Day 8) | 20.0 Breaths/minute | — |
Primary
Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented.
Time frame: Up to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Test of Cure | 131.3 Millimeters of mercury (mmHg) | Standard Deviation 5.85 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: End of IV therapy | 74.0 Millimeters of mercury (mmHg) | Standard Deviation 9.94 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 8) | 90.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Early Follow-up | 128.0 Millimeters of mercury (mmHg) | Standard Deviation 17.03 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 5) | 135.2 Millimeters of mercury (mmHg) | Standard Deviation 27.58 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 7) | 85.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Late Follow-up | 148.0 Millimeters of mercury (mmHg) | Standard Deviation 23.64 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Early Follow-up | 73.8 Millimeters of mercury (mmHg) | Standard Deviation 9.62 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 6) | 90.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline (Day 1) | 68.0 Millimeters of mercury (mmHg) | Standard Deviation 12.84 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 14) | 69.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 5) | 83.8 Millimeters of mercury (mmHg) | Standard Deviation 13.95 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 2) | 78.3 Millimeters of mercury (mmHg) | Standard Deviation 12.82 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 6) | 150.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 4) | 85.5 Millimeters of mercury (mmHg) | Standard Deviation 15.73 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 3) | 77.2 Millimeters of mercury (mmHg) | Standard Deviation 12.22 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 3) | 123.8 Millimeters of mercury (mmHg) | Standard Deviation 15.09 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 13) | 80.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 7) | 165.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 2) | 131.2 Millimeters of mercury (mmHg) | Standard Deviation 15.2 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 12) | 75.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 8) | 170.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Test of Cure | 82.2 Millimeters of mercury (mmHg) | Standard Deviation 5.88 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 11) | 69.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 9) | 161.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 4) | 137.8 Millimeters of mercury (mmHg) | Standard Deviation 17.61 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 10) | 69.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 10) | 140.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 9) | 95.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 11) | 155.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 12) | 140.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 13) | 130.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 14) | 152.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: End of IV therapy | 130.0 Millimeters of mercury (mmHg) | Standard Deviation 17.03 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Late Follow-up | 87.7 Millimeters of mercury (mmHg) | Standard Deviation 16.18 |
| GSK2251052 750 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline (Day 1) | 129.7 Millimeters of mercury (mmHg) | Standard Deviation 29.27 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 8) | 69.0 Millimeters of mercury (mmHg) | Standard Deviation 15.56 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline (Day 1) | 131.9 Millimeters of mercury (mmHg) | Standard Deviation 14.56 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 2) | 125.4 Millimeters of mercury (mmHg) | Standard Deviation 15.89 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 3) | 126.6 Millimeters of mercury (mmHg) | Standard Deviation 28.69 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 4) | 127.0 Millimeters of mercury (mmHg) | Standard Deviation 30.79 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 5) | 126.6 Millimeters of mercury (mmHg) | Standard Deviation 35.1 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 6) | 125.5 Millimeters of mercury (mmHg) | Standard Deviation 34.65 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 7) | 125.0 Millimeters of mercury (mmHg) | Standard Deviation 21.21 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 8) | 125.0 Millimeters of mercury (mmHg) | Standard Deviation 49.5 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 9) | 130.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: End of IV therapy | 116.1 Millimeters of mercury (mmHg) | Standard Deviation 13.93 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Test of Cure | 126.9 Millimeters of mercury (mmHg) | Standard Deviation 27.17 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Early Follow-up | 120.1 Millimeters of mercury (mmHg) | Standard Deviation 15.24 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Late Follow-up | 117.6 Millimeters of mercury (mmHg) | Standard Deviation 21.77 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline (Day 1) | 77.3 Millimeters of mercury (mmHg) | Standard Deviation 9.25 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 2) | 69.0 Millimeters of mercury (mmHg) | Standard Deviation 15.61 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 3) | 72.1 Millimeters of mercury (mmHg) | Standard Deviation 15.72 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 4) | 79.5 Millimeters of mercury (mmHg) | Standard Deviation 19.41 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 5) | 79.7 Millimeters of mercury (mmHg) | Standard Deviation 21.89 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 6) | 81.0 Millimeters of mercury (mmHg) | Standard Deviation 12.73 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 7) | 70.0 Millimeters of mercury (mmHg) | Standard Deviation 0 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 9) | 80.0 Millimeters of mercury (mmHg) | — |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: End of IV therapy | 69.4 Millimeters of mercury (mmHg) | Standard Deviation 17.22 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Test of Cure | 70.6 Millimeters of mercury (mmHg) | Standard Deviation 12.47 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Early Follow-up | 72.0 Millimeters of mercury (mmHg) | Standard Deviation 11.72 |
| GSK2251052 1500 mg | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Late Follow-up | 67.5 Millimeters of mercury (mmHg) | Standard Deviation 16.13 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 6) | 72.5 Millimeters of mercury (mmHg) | Standard Deviation 15 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Early Follow-up | 123.8 Millimeters of mercury (mmHg) | Standard Deviation 13.1 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 2) | 120.0 Millimeters of mercury (mmHg) | Standard Deviation 19.75 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 7) | 67.7 Millimeters of mercury (mmHg) | Standard Deviation 9.29 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Test of Cure | 126.4 Millimeters of mercury (mmHg) | Standard Deviation 20.12 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: End of IV therapy | 117.5 Millimeters of mercury (mmHg) | Standard Deviation 11.73 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 8) | 70.0 Millimeters of mercury (mmHg) | — |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 10) | 110.0 Millimeters of mercury (mmHg) | — |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Late Follow-up | 65.0 Millimeters of mercury (mmHg) | Standard Deviation 5.29 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 9) | 65.0 Millimeters of mercury (mmHg) | — |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 9) | 105.0 Millimeters of mercury (mmHg) | — |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 10) | 70.0 Millimeters of mercury (mmHg) | — |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 8) | 110.0 Millimeters of mercury (mmHg) | — |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 7) | 116.7 Millimeters of mercury (mmHg) | Standard Deviation 20.82 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 6) | 115.0 Millimeters of mercury (mmHg) | Standard Deviation 12.25 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 5) | 116.8 Millimeters of mercury (mmHg) | Standard Deviation 18.42 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 4) | 124.2 Millimeters of mercury (mmHg) | Standard Deviation 17.98 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Early Follow-up | 68.8 Millimeters of mercury (mmHg) | Standard Deviation 12.05 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: End of IV therapy | 71.5 Millimeters of mercury (mmHg) | Standard Deviation 12.42 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 3) | 71.2 Millimeters of mercury (mmHg) | Standard Deviation 3.56 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 2) | 70.3 Millimeters of mercury (mmHg) | Standard Deviation 10.78 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: On IV therapy (Day 3) | 123.8 Millimeters of mercury (mmHg) | Standard Deviation 13.88 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 4) | 69.6 Millimeters of mercury (mmHg) | Standard Deviation 5.77 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Baseline (Day 1) | 66.5 Millimeters of mercury (mmHg) | Standard Deviation 4.64 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Baseline (Day 1) | 120.0 Millimeters of mercury (mmHg) | Standard Deviation 17.64 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: On IV therapy (Day 5) | 67.0 Millimeters of mercury (mmHg) | Standard Deviation 4.12 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | SBP: Late Follow-up | 116.6 Millimeters of mercury (mmHg) | Standard Deviation 13.35 |
| Imipenem-Cilastatin | Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | DBP: Test of Cure | 71.8 Millimeters of mercury (mmHg) | Standard Deviation 15.14 |
Primary
Summary of Vital Signs- Mean Temperature
Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF).
Time frame: Up to Late Follow up Visit (21 to 28 days post-IV therapy)
Population: Safety Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 7) | 36.20 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 2) | 36.97 Celsius | Standard Deviation 1.063 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 13) | 36.20 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 8) | 36.80 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | Test of Cure | 36.25 Celsius | Standard Deviation 0.418 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 12) | 36.80 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 9) | 36.50 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 4) | 36.60 Celsius | Standard Deviation 0.469 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 11) | 37.00 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 10) | 37.00 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | Late Follow-up | 36.40 Celsius | Standard Deviation 0.11 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | Baseline (Day 1) | 38.08 Celsius | Standard Deviation 0.741 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 5) | 36.27 Celsius | Standard Deviation 0.378 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | Early Follow-up | 36.23 Celsius | Standard Deviation 0.427 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | End of IV therapy | 36.18 Celsius | Standard Deviation 0.512 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 6) | 37.00 Celsius | — |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 3) | 36.75 Celsius | Standard Deviation 0.706 |
| GSK2251052 750 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 14) | 36.80 Celsius | — |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | End of IV therapy | 36.75 Celsius | Standard Deviation 0.676 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | Baseline (Day 1) | 38.41 Celsius | Standard Deviation 0.946 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 2) | 37.30 Celsius | Standard Deviation 0.693 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 3) | 36.79 Celsius | Standard Deviation 0.38 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 4) | 36.71 Celsius | Standard Deviation 0.669 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 5) | 36.59 Celsius | Standard Deviation 0.498 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 6) | 36.90 Celsius | Standard Deviation 1.273 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 7) | 36.95 Celsius | Standard Deviation 0.778 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 8) | 36.80 Celsius | Standard Deviation 0.707 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 9) | 36.80 Celsius | — |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | Test of Cure | 35.98 Celsius | Standard Deviation 0.709 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | Early Follow-up | 35.99 Celsius | Standard Deviation 0.387 |
| GSK2251052 1500 mg | Summary of Vital Signs- Mean Temperature | Late Follow-up | 36.08 Celsius | Standard Deviation 0.512 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 7) | 36.93 Celsius | Standard Deviation 0.416 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 6) | 36.40 Celsius | Standard Deviation 0.283 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 5) | 36.96 Celsius | Standard Deviation 0.654 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 4) | 37.38 Celsius | Standard Deviation 0.986 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | End of IV therapy | 36.38 Celsius | Standard Deviation 0.299 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 3) | 37.74 Celsius | Standard Deviation 0.817 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | Baseline (Day 1) | 38.30 Celsius | Standard Deviation 0.469 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | Test of Cure | 36.14 Celsius | Standard Deviation 0.744 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 2) | 37.30 Celsius | Standard Deviation 0.86 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | Late Follow-up | 36.00 Celsius | Standard Deviation 0.394 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | Early Follow-up | 36.28 Celsius | Standard Deviation 0.606 |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 10) | 36.50 Celsius | — |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 9) | 36.50 Celsius | — |
| Imipenem-Cilastatin | Summary of Vital Signs- Mean Temperature | On IV therapy (Day 8) | 36.50 Celsius | — |
Primary
Therapeutic Response at the Test of Cure Visit
The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.
Time frame: Test of Cure Visit (5 to 9 days post-IV therapy)
Population: Microbiological Intent to Treat (MITT) comprised of all randomized participants who received at least one dose of study medication and had at least one gram-negative uropathogen and no more than two gram-negative uropathogens (≥10\^5 Colony forming units \[CFU\]/mL for each pathogen) identified from Baseline urine culture.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK2251052 750 mg | Therapeutic Response at the Test of Cure Visit | Therapeutic Success | 1 Participants |
| GSK2251052 750 mg | Therapeutic Response at the Test of Cure Visit | Therapeutic Failure | 5 Participants |
| GSK2251052 1500 mg | Therapeutic Response at the Test of Cure Visit | Therapeutic Success | 5 Participants |
| GSK2251052 1500 mg | Therapeutic Response at the Test of Cure Visit | Therapeutic Failure | 3 Participants |
| Imipenem-Cilastatin | Therapeutic Response at the Test of Cure Visit | Therapeutic Success | 1 Participants |
| Imipenem-Cilastatin | Therapeutic Response at the Test of Cure Visit | Therapeutic Failure | 4 Participants |
Secondary
Area Under the Concentration Time Curve (AUC) of GSK2251052
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose
Secondary
AUC of GSK2251052 Using Intensive PK Sampling
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose
Secondary
AUC of GSK2251052 Using Non-intensive PK Sampling
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose
Secondary
Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit
Clinical response was a combination of clinical success and clinical failure. In clinical success, participants showed no signs and symptoms of pyelonephritis and lower complicated urinary tract infection and antibiotics are not used for the same. In clinical failure, there is reappearance of signs and symptoms of and lower complicated urinary tract infection and participant required antibiotics for the same.
Time frame: End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)
Population: MITT Population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK2251052 750 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Clinical Success | 4 Participants |
| GSK2251052 750 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Clinical Failure | 2 Participants |
| GSK2251052 750 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Clinical Success | 4 Participants |
| GSK2251052 750 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Clinical Failure | 2 Participants |
| GSK2251052 750 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Follow-up | Clinical Success | 3 Participants |
| GSK2251052 750 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Follow-up | Clinical Failure | 3 Participants |
| GSK2251052 1500 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Follow-up | Clinical Failure | 2 Participants |
| GSK2251052 1500 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Clinical Success | 6 Participants |
| GSK2251052 1500 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Clinical Failure | 2 Participants |
| GSK2251052 1500 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Follow-up | Clinical Success | 6 Participants |
| GSK2251052 1500 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Clinical Failure | 2 Participants |
| GSK2251052 1500 mg | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Clinical Success | 6 Participants |
| Imipenem-Cilastatin | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Clinical Failure | 0 Participants |
| Imipenem-Cilastatin | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Clinical Success | 4 Participants |
| Imipenem-Cilastatin | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Follow-up | Clinical Failure | 3 Participants |
| Imipenem-Cilastatin | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Clinical Failure | 1 Participants |
| Imipenem-Cilastatin | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Clinical Success | 5 Participants |
| Imipenem-Cilastatin | Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Follow-up | Clinical Success | 2 Participants |
Secondary
Cmax of GSK2251052 Using Intensive PK Sampling
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose
Secondary
Cmax of GSK2251052 Using Non-intensive PK Sampling
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose
Secondary
Maximum Plasma Concentration (Cmax) of GSK2251052
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose
Secondary
Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit
Microbiological response involved both microbiological success and microbiological failure. A reduction in the uropathogens in the urine culture and no growth on blood culture was termed as microbiological success. Increase in the uropathogens in the urine culture and pathogens identified in the blood culture or use of antibacterials other than study treatments were classified as microbiological failures.
Time frame: End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)
Population: MITT Population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK2251052 750 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Microbiological Success | 3 Participants |
| GSK2251052 750 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Microbiological Failure | 3 Participants |
| GSK2251052 750 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Microbiological Success | 1 Participants |
| GSK2251052 750 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Microbiological Failure | 5 Participants |
| GSK2251052 750 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Folllow-up | Microbiological Success | 2 Participants |
| GSK2251052 750 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Folllow-up | Microbiological Failure | 4 Participants |
| GSK2251052 1500 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Folllow-up | Microbiological Failure | 2 Participants |
| GSK2251052 1500 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Microbiological Success | 5 Participants |
| GSK2251052 1500 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Microbiological Failure | 3 Participants |
| GSK2251052 1500 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Folllow-up | Microbiological Success | 6 Participants |
| GSK2251052 1500 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Microbiological Failure | 3 Participants |
| GSK2251052 1500 mg | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Microbiological Success | 5 Participants |
| Imipenem-Cilastatin | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Microbiological Failure | 0 Participants |
| Imipenem-Cilastatin | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Microbiological Success | 1 Participants |
| Imipenem-Cilastatin | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Folllow-up | Microbiological Failure | 4 Participants |
| Imipenem-Cilastatin | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Test of Cure | Microbiological Failure | 4 Participants |
| Imipenem-Cilastatin | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | End of IV therapy | Microbiological Success | 5 Participants |
| Imipenem-Cilastatin | Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit | Late Folllow-up | Microbiological Success | 1 Participants |
Secondary
Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit
The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response.
Time frame: End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)
Population: MITT Population.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| GSK2251052 750 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy | Therapeutic Success | 3 Participants |
| GSK2251052 750 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy | Therapeutic Failure | 3 Participants |
| GSK2251052 750 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | Late Follow-up | Therapeutic Success | 2 Participants |
| GSK2251052 750 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | Late Follow-up | Therapeutic Failure | 4 Participants |
| GSK2251052 1500 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | Late Follow-up | Therapeutic Failure | 2 Participants |
| GSK2251052 1500 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy | Therapeutic Success | 5 Participants |
| GSK2251052 1500 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | Late Follow-up | Therapeutic Success | 6 Participants |
| GSK2251052 1500 mg | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy | Therapeutic Failure | 3 Participants |
| Imipenem-Cilastatin | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | Late Follow-up | Therapeutic Failure | 4 Participants |
| Imipenem-Cilastatin | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy | Therapeutic Failure | 0 Participants |
| Imipenem-Cilastatin | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | Late Follow-up | Therapeutic Success | 1 Participants |
| Imipenem-Cilastatin | Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit | End of IV therapy | Therapeutic Success | 5 Participants |
Secondary
Time to Cmax (Tmax) of GSK2251052
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 3: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose
Secondary
Tmax of GSK2251052 Using Intensive PK Sampling
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 4: Pre-dose (just prior to the start of the first infusion of the day) 0.5, 1 hour (just prior to the end of the infusion), 1.25, 1.5, 2, 3, 4, 8 and 12 hours post-dose
Secondary
Tmax of GSK2251052 Using Non-intensive PK Sampling
The planned pharmacokinetic (PK) and PK/pharmacodynamic analyses were not performed, because the PK data was not collected.
Time frame: Day 4: Pre- dose (just prior to the start of the first infusion of the day) and 1 hour (just prior to the end of the infusion), 2, 4, and 12 hours post-dose