Epilepsy
Conditions
Keywords
Retigabine, Drug-Resistant, Epilepsy, Partial-Onset Seizures, Safety and Tolerability, Immediate Release, Long-Term, Adjunctive Therapy, Asian Subjects, Efficacy, GW582892
Brief summary
This is a multicentre, long-term, open-label extension (OLE) study to assess the long-term safety, tolerability and efficacy of retigabine immediate-release (IR) as adjunctive therapy in adult Asian subjects with drug-resistant partial-onset seizures (POS).
Detailed description
Subjects who successfully complete the Maintenance Phase of Study RTG114855 (parent study) and are expected to benefit from therapy with retigabine IR will be eligible for this OLE study. The study will consist of Screening (1 day), Open-Label Treatment and Follow-up (3 weeks) phase. Subjects will initially receive a starting dose of retigabine IR at 900 milligram (mg)/day and the same concurrent antiepileptic drug (AED) regimen that they were receiving at the final visit of the Transition Phase of the parent study. After the first week of the OLE study, the dose of retigabine IR may be adjusted to between 600 and 1200 mg/day, with dose adjustments in increments or decrements of 150 mg/week, based on efficacy and tolerability. In addition, the dose and number of concurrent AEDs may also be adjusted to meet each individual subject's needs. The efficacy and safety issues will be assessed throughout the study; subjects will be instructed to call the investigator if they experience any efficacy or tolerability issues between the study visits. As the duration of the study will be determined based on the following four conditions: 1) regulatory approval and commercialisation of retigabine IR; 2) retigabine IR is not approved by the regulatory authorities; 3) the study is terminated by the Sponsor for reasons including, but not limited to, safety issues; or 4) the subject is withdrawn or withdraws consent, 4 years will be considered as a guide to the duration of the study. The safety and tolerability endpoints are incidence and severity of adverse events (AEs); proportion of subjects with AEs leading to discontinuation; change from Baseline in vital sign measurements and weight; change from Baseline in electrocardiogram parameters; change from Baseline in haematology, chemistry, and urinalysis parameters; changes from Baseline in American Urological Association Symptom Index and post-void residual bladder ultrasound volumes; and summary of the Columbia-Suicide Severity Rating Scale. Efficacy will be assessed by calculating the percent change from Baseline (parent study) in 28-day total POS frequency for the entire open-label Treatment Phase of this OLE study. This will also be calculated based on duration of exposure. Responder rate (defined as a \>/=50% reduction from Baseline in 28-day total POS frequency) will also be summarised for the entire open-label Treatment Phase and by duration of exposure.
Interventions
DRUGRetigabine IR
Retigabine IR tablets will be available in 5 strengths: 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The subject has successfully completed the Maintenance Phase and Transition Phase of Study RTG114855. * The subject is expected, in the opinion of the investigator, to benefit from participation in this OLE study. * The subject or the caregiver is able and willing to maintain an accurate and complete written daily seizure calendar for the entire duration of the study. * The subject has given written informed consent, or has a legally authorized representative who has given written informed consent, prior to the performance of any study assessments. * A female subject is eligible to enrol and participate in the study if she is of: nonchildbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is premenarchal or postmenopausal), premenopausal females with a documented (medical report verification) hysterectomy with or without oophorectomy, or bilateral oophorectomy when reproductive status has been confirmed by hormone level assessment, and postmenopausal females defined as being amenorrhoeic for \>1 year with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms). However, if indicated, this should be confirmed by oestradiol and follicle stimulating hormone levels consistent with menopause (according to local laboratory ranges). Women who have not been confirmed as postmenopausal should be advised to use contraception. * Childbearing potential, has a negative urine or serum pregnancy test at Screening. * Is not pregnant or lactating or planning to become pregnant during the study.
Exclusion criteria
* Has met any of the withdrawal criteria in the parent study (RTG114855) or has, in the opinion of the investigator, clinically significant abnormal laboratory or ECG findings that preclude entry into RTG114873. * Is planning to begin treatment with an investigational drug (other than retigabine) and/or an experimental device for the treatment of epilepsy or any other medical condition. * Has any medical condition that, in the investigator's judgement, is considered to be clinically significant and could potentially affect subject safety or study outcome, including but not limited to clinically significant cardiac, renal, or hepatic condition; or a condition that affects the absorption, distribution, metabolism, or excretion of drugs. * Is unwilling or unable to follow the study procedures or reporting of AEs. * Has active suicidal plan/intent or has had active suicidal thoughts in the past 6 months or has history of suicide attempt in the last 2 years or \>1 lifetime suicide attempt.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs | Up to 4 years | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function is SAE. TEAE refers to an AE for which the onset was on or after the date of the first RTG dose in this study and on or before 30 days after the last RTG dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Safety population comprised of participants who take at least 1 dose of study medication after they have enrolled into this OLE study. Number of participants with TE-SAEs and non-SAEs (with incidence \>= 5%) have been presented. |
| Percentage of Participants With TEAEs Leading to Study Discontinuation | Up to 4 years | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE refers to an AE for which the onset was on or after the date of the first RTG dose in this study and on or before 30 days after the last RTG dose date. Percentage of participants with TEAEs leading to study discontinuation were presented. |
| Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | Baseline and up to 4 years | The vital signs were evaluated as per PCC Criteria. The vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The vital signs were measured in a seated position after 5 minutes of rest. PCC range for DBP was increase or decrease of \>=20, for SBP was increase or decrease of \>=15 and for heart rate was increase or decrease of \>=15. A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with vital sign values of PCC at any Post-Baseline visit were presented. |
| Number of Participants With PCC Values of Change From Baseline for Body Weight | Baseline and up to 4 years | Body weight of participants were measured as a measure of safety. PCC range for body weight was increase or decrease of \>=7 percent. A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with PCC values of body weight at any Post-Baseline visit were presented. |
| Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | Baseline and up to 4 years | Single measurements of 12-lead ECGs were obtained in a supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate (HR) as beats per minute (bpm) and measures PR, QRS, Bazett's correction QT interval (QTcB) and Friedericia's correction QT interval (QTcF) in milliseconds (msec). A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with PCC values of ECG parameters at any Post-Baseline visit were presented. For the 'Any Post Baseline' value, only the worst case finding was counted for each participant. |
| Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Baseline and up to 4 years | Blood samples were collected from participants for evaluation of change from Baseline in hematology parameters including basophils, eosinophils, lymphocytes,monocytes, platelet count, total neutrophils, and WBC. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were calculated. |
| Change From Baseline in Hematocrit | Baseline and up to 4 years | Blood samples were collected from participants for evaluation of hematocrit. Hematocrit is a ratio of red blood cells to the total volume of blood. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in hemoglobin and MCHC levels. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in MCH levels. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in MCV and MPV levels. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Red Blood Cell (RBC) Count | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in RBC count. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Red Cell Distribution Width (RDW) | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in RDW. RDW is a parameter that measures variation in red blood cell size or red blood cell volume. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Baseline and up to 4 years | Blood samples collected from participants to evaluate change from Baseline in clinical chemistry parameters included ALT, Alk. phosph., AST,CK, GGT and LD. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Albumin and Total Protein | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in albumin and total protein. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in BUN/creatinine. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in calcium, CO2 content/Bicarb, chloride, glucose, magnesium, potassium, sodium, and urea/BUN. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Baseline and up to 4 years | Blood samples were collected from participants to evaluate change from Baseline in creatinine, direct bilirubin, total bilirubin, and uric acid. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in Urine Albumin/Creatinine Ratio | Baseline and up to 4 years | Urine samples were collected from participants to evaluate change from Baseline in urine albumin/creatinine ratio. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. NA indicates data was not available as standard deviation could not be calculated for single participant. |
| Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Up to 4 years | Urine samples were collected from participants to analyze presence of abnormal urinalysis parameters including glucose, ketones, RBC, WBC, occult blood and protein. Abnormal urinalysis values have been presented for all parameters. Only those participants with data available at specific time points were analyzed (represented by n= X in the category titles). |
| Specific Gravity of Urine at Indicated Time Points | Up to 4 years | Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Potential of Hydrogen (pH) of Urine at Indicated Time Points | Up to 4 years | Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Urine Creatinine Concentration | Baseline and up to 4 years | Urine samples were collected from participants to evaluate change from Baseline in Urine creatinine concentration. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Baseline and up to 4 years | The effect of RTG on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale with seven questions, each with six potential responses. Responses to each of 7 questions were scored from 0 (no symptom at all) to 5 (almost always symptoms present) which were summmed to get total possible score ranging from 0 to 35 with higher scores indicating worse symptom severity. The total score for all questions was classified as mild (0-7), moderate (8-19) or severe (\>19). Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). |
| Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Baseline and up to 4 years | The PVR bladder ultrasound was used to assess the effects of RTG on bladder function. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. |
| Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to 4 years | Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. It consists of an assessment of suicidal ideation (ranging from desire to be dead to active suicidal ideation with specific plan and intent) and an assessment of suicidal behavior (ranging from preparatory acts or behavior to completed suicide). |
| Number of Participants Who Discontinued From RTG | Up to 4 years | The number of participants who discontinued from RTG treatment has been presented. |
| Percentage of Participants With Retinal Pigmentary Abnormalities | Up to 4 years | Percentage of participants with abnormal findings after eye examination were evaluated. Abnormalities detected on-treatment in study RTG114873 were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location. |
| Percentage of Participants With Pigmentation of Non-retinal Ocular Tissues | Up to 4 years | Percentage of participants with abnormal findings after eye examination were evaluated. Abnormalities detected on-treatment in study RTG114873 were presented. Pigmentation of non-retinal ocular tissues included pigmentation of the sclera and/or conjunctiva, cornea, iris and lens. |
| Percentage of Participants With Dermatologist-confirmed Abnormal Discoloration | Up to 4 years | Percentage of participants with abnormal findings after skin examination (including the skin around the eyes and the eyelids, lips, nails, or mucosa) were evaluated. |
| Percentage of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | Up to 4 years | Percentage of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment in study RTG114873 were presented. |
| Percentage of Participants With Decrease in Confrontational Visual Field From Initial Examination | Up to 4 years | Percentage of participants with decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment in study RTG114873 were presented. |
| Percentage of Responders to POS Frequency | Up to 4 years | A responder was defined as a participant experiencing a \>=50 percent reduction in 28 day total POS frequency from Baseline. A responder rate was calculated overall and based on duration of exposure. As this was an OLE study, Baseline was defined by the parent study Baseline period. Percentage of responders were evaluated from study RTG114873 Day 1 through the last dosing day, excluding the Taper Phase. |
| Percent Change From Baseline in 28-day Total POS Frequency | Baseline and up to 4 years | The 28-day total POS frequency was calculated as the number of total POS reported during the treatment phase, divided by the number of applicable days in the treatment phase, then multiplying this ratio by 28. In this formula, innumerable seizures were counted as 10 seizures and status epilepticus was counted as 1 seizure. As this was an OLE study, Baseline was defined by the parent study Baseline period. The percent change from Baseline was calculated as the 28-day total POS on-treatment frequency (during dosing in this study, not including the taper phase) minus the Baseline 28-day total POS frequency, with this difference being divided by the Baseline 28-day partial seizure rate, and the resulting quantity multiplied by 100. It was calculated as overall and by duration of exposure. Mean and SD were presented. |
| Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of RTG | Up to 1.4 years | The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. This analysis was performed on the All SFUCP Subjects population which comprised of all participants who enter the SFUCP. |
| Number of Participants With Resolution of Dermatologist-confirmed Abnormal Discoloration After Discontinuation of RTG | Up to 1.4 years | The skin examination included assessment of the skin around the eyes and the eye lids, lips, nails, and mucosa. Participants who enter the SFUCP who had on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist, underwent assessments performed by a dermatologist at 6-monthly intervals. |
Countries
Malaysia, South Korea, Thailand
Participant flow
Recruitment details
Participants with partial-onset seizures (POS) who successfully completed the maintenance phase of study RTG114855 (NCT01648101) were recruited in this open-label extension (OLE) study.
Pre-assignment details
All the participants received at least 1 dose of retigabine (RTG) immediate release (IR). Screening was performed on the day of final visit of the parent study. A total of 30 participants, 12 from placebo and 18 from RTG group who completed the treatment and transition phases of the parent study were included in this OLE study.
Participants by arm
| Arm | Count |
|---|---|
| RTG IR Eligible participants initially received a starting dose of RTG IR 900 milligrams per day (mg/day) and the same doses of the same concurrent anti-epileptic drugs (AEDs) that they were receiving at the final visit of the transition phase of the parent study. After the first week of the OLE study, the dose of RTG IR could be increased or decreased in increments or decrements 150 mg/day on weekly basis based on efficacy and tolerability. The overall daily dose of RTG IR was to be maintained between a minimum dose of 600 mg/day and a maximum dose of 1200 mg/day. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Primary Reporting Phase (Up to 4 Years) | Adverse Event | 7 | 0 |
| Primary Reporting Phase (Up to 4 Years) | Lack of Efficacy | 6 | 0 |
| Primary Reporting Phase (Up to 4 Years) | Other (Reached stopping criteria) | 2 | 0 |
| Primary Reporting Phase (Up to 4 Years) | Other (Study drug discontinued) | 3 | 0 |
| Primary Reporting Phase (Up to 4 Years) | Other (Subjects entered SFUCP) | 4 | 0 |
| Primary Reporting Phase (Up to 4 Years) | Withdrawal by Subject | 8 | 0 |
| SFUCP (Up to 1.4 Years) | Other-Study drug discontinued | 0 | 3 |
| SFUCP (Up to 1.4 Years) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | RTG IR |
|---|---|
| Age, Continuous | 36.0 Years STANDARD_DEVIATION 9.25 |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 17 Participants |
| Race/Ethnicity, Customized Asian-Mixed Race | 1 Participants |
| Race/Ethnicity, Customized Asian-South East Asian Heritage | 12 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 4 |
| other Total, other adverse events | 23 / 30 | 0 / 4 |
| serious Total, serious adverse events | 5 / 30 | 0 / 4 |
Outcome results
Primary
Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD)
Blood samples collected from participants to evaluate change from Baseline in clinical chemistry parameters included ALT, Alk. phosph., AST,CK, GGT and LD. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Follow-Up Visit; n=4 | -3.8 International unit per liter (IU/L) | Standard Deviation 9.03 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 1-Day 1; n=27 | -1.4 International unit per liter (IU/L) | Standard Deviation 20.13 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 2 - Month 1; n=26 | 0.8 International unit per liter (IU/L) | Standard Deviation 22.57 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 3 - Month 3; n=24 | 1.7 International unit per liter (IU/L) | Standard Deviation 17.96 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 4 - Month 6; n=19 | -8.5 International unit per liter (IU/L) | Standard Deviation 19.35 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 5 - Month 9; n=17 | 1.9 International unit per liter (IU/L) | Standard Deviation 17.71 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 6 - Month 12; n=15 | -1.6 International unit per liter (IU/L) | Standard Deviation 22.21 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 7-(Month 16); n=14 | 1.3 International unit per liter (IU/L) | Standard Deviation 21.21 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 8 - (Month 20); n=12 | -0.5 International unit per liter (IU/L) | Standard Deviation 12.08 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 9 - (Month 24); n=11 | 12.2 International unit per liter (IU/L) | Standard Deviation 8.4 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 10-(Month 28); n=9 | 8.3 International unit per liter (IU/L) | Standard Deviation 16.65 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 11-(Month 32); n=9 | 18.8 International unit per liter (IU/L) | Standard Deviation 18.98 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Visit 12-(Month 36); n=4 | 8.5 International unit per liter (IU/L) | Standard Deviation 7.9 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Study Conclusion/Withdrawal; n=27 | 2.6 International unit per liter (IU/L) | Standard Deviation 23.41 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | LD; Follow-Up Visit; n=4 | 2.5 International unit per liter (IU/L) | Standard Deviation 8.19 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 1-Day 1; n= 28 | 0.8 International unit per liter (IU/L) | Standard Deviation 4.78 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 2 - Month 1; n=27 | 3.3 International unit per liter (IU/L) | Standard Deviation 14.86 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 3 - Month 3; n=24 | 0.3 International unit per liter (IU/L) | Standard Deviation 5.44 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 4 - Month 6; n=19 | 0.9 International unit per liter (IU/L) | Standard Deviation 6.2 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 5 - Month 9; n=17 | 0.6 International unit per liter (IU/L) | Standard Deviation 4.17 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 6 - Month 12; n=15 | 1.5 International unit per liter (IU/L) | Standard Deviation 6.41 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 7 (Month 16); n=14 | 0.3 International unit per liter (IU/L) | Standard Deviation 4.61 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 8 (Month 20); n=12 | 0.4 International unit per liter (IU/L) | Standard Deviation 4.62 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 9 (Month 24); n=11 | 0.8 International unit per liter (IU/L) | Standard Deviation 8.59 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 10 (Month 28); n=10 | 1.6 International unit per liter (IU/L) | Standard Deviation 6 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 11 (Month 32); n=9 | 7.4 International unit per liter (IU/L) | Standard Deviation 13.57 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Visit 12 (Month 36); n=4 | 0.0 International unit per liter (IU/L) | Standard Deviation 5.29 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT; Study Conclusion/Withdrawal; n=27 | 1.1 International unit per liter (IU/L) | Standard Deviation 6.05 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | ALT ; Follow-Up Visit; n=4 | 9.8 International unit per liter (IU/L) | Standard Deviation 15.65 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph.; Visit 1-Day 1; n= 28 | -1.5 International unit per liter (IU/L) | Standard Deviation 13.64 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 2 - Month 1; n=27 | -2.2 International unit per liter (IU/L) | Standard Deviation 12.43 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 3 - Month 3; n=24 | -2.5 International unit per liter (IU/L) | Standard Deviation 17.09 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 4 - Month 6; n=19 | -5.1 International unit per liter (IU/L) | Standard Deviation 13.82 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 5 - Month 9; n=17 | -4.7 International unit per liter (IU/L) | Standard Deviation 14.5 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 6 - Month 12; n=15 | -2.5 International unit per liter (IU/L) | Standard Deviation 18.28 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 7 (Month 16); n=14 | 0.2 International unit per liter (IU/L) | Standard Deviation 20.1 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 8 (Month 20); n=12 | 0.5 International unit per liter (IU/L) | Standard Deviation 19.15 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 9 (Month 24); n=11 | -3.5 International unit per liter (IU/L) | Standard Deviation 16.42 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 10 (Month 28); n=10 | -5.3 International unit per liter (IU/L) | Standard Deviation 12.68 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 11 (Month 32); n=9 | 5.8 International unit per liter (IU/L) | Standard Deviation 15.91 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Visit 12 (Month 36); n=4 | 7.8 International unit per liter (IU/L) | Standard Deviation 18.03 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph; Study Conclusion/Withdrawal; n=27 | -2.7 International unit per liter (IU/L) | Standard Deviation 16.65 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | Alk. Phosph ; Follow-Up Visit; n=4 | -21.3 International unit per liter (IU/L) | Standard Deviation 19.69 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 1-Day 1; n= 27 | 0.5 International unit per liter (IU/L) | Standard Deviation 6.35 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 2 - Month 1; n=26 | 2.0 International unit per liter (IU/L) | Standard Deviation 10.61 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 3 - Month 3; n=24 | 0.0 International unit per liter (IU/L) | Standard Deviation 4.57 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 4 - Month 6; n=19 | 1.3 International unit per liter (IU/L) | Standard Deviation 4.13 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 5 - Month 9; n=17 | 2.6 International unit per liter (IU/L) | Standard Deviation 6.02 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 6 - Month 12; n=15 | 2.1 International unit per liter (IU/L) | Standard Deviation 5.42 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 7 (Month 16); n=14 | 1.8 International unit per liter (IU/L) | Standard Deviation 3.17 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 8 (Month 20); n=12 | 1.6 International unit per liter (IU/L) | Standard Deviation 3.32 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 9 (Month 24); n=11 | 2.5 International unit per liter (IU/L) | Standard Deviation 4.3 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 10 (Month 28); n=9 | 2.9 International unit per liter (IU/L) | Standard Deviation 4.88 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 11 (Month 32); n=9 | 4.7 International unit per liter (IU/L) | Standard Deviation 4.58 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Visit 12 (Month 36); n=4 | 0.8 International unit per liter (IU/L) | Standard Deviation 2.5 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Study Conclusion/Withdrawal; n=27 | 1.5 International unit per liter (IU/L) | Standard Deviation 6.08 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | AST; Follow-Up Visit; n=4 | 7.5 International unit per liter (IU/L) | Standard Deviation 10.34 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 1-Day 1; n= 28 | -103.3 International unit per liter (IU/L) | Standard Deviation 483.91 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 2 - Month 1; n=27 | -72.5 International unit per liter (IU/L) | Standard Deviation 414.16 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 3 - Month 3; n=24 | -88.8 International unit per liter (IU/L) | Standard Deviation 461.41 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 4 - Month 6; n=19 | -10.3 International unit per liter (IU/L) | Standard Deviation 56.38 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 5 - Month 9; n=17 | -10.9 International unit per liter (IU/L) | Standard Deviation 63.16 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 6 - Month 12; n=15 | 11.9 International unit per liter (IU/L) | Standard Deviation 62.4 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 7-(Month 16); n=14 | 9.2 International unit per liter (IU/L) | Standard Deviation 23.66 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 8 -(Month 20); n=12 | 1.3 International unit per liter (IU/L) | Standard Deviation 21.83 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 9 -(Month 24); n=11 | 4.8 International unit per liter (IU/L) | Standard Deviation 35.02 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 10-(Month 28); n=10 | 2.6 International unit per liter (IU/L) | Standard Deviation 27.47 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 11-(Month 32); n=9 | 93.7 International unit per liter (IU/L) | Standard Deviation 185.31 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Visit 12-(Month 36); n=4 | 26.3 International unit per liter (IU/L) | Standard Deviation 51.06 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Study Conclusion/Withdrawal; n=27 | 24.7 International unit per liter (IU/L) | Standard Deviation 658.19 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | CK; Follow-Up Visit; n=4 | 261.0 International unit per liter (IU/L) | Standard Deviation 553.52 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 1-Day 1; n= 28 | 4.6 International unit per liter (IU/L) | Standard Deviation 21.15 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 2 - Month 1; n=27 | 4.2 International unit per liter (IU/L) | Standard Deviation 37.01 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 3 - Month 3; n=24 | -4.5 International unit per liter (IU/L) | Standard Deviation 24.84 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 4 - Month 6; n=19 | -2.7 International unit per liter (IU/L) | Standard Deviation 18.93 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 5 - Month 9; n=17 | -2.5 International unit per liter (IU/L) | Standard Deviation 31.07 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 6 - Month 12; n=15 | -4.7 International unit per liter (IU/L) | Standard Deviation 21.26 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 7-(Month 16); n=14 | -3.6 International unit per liter (IU/L) | Standard Deviation 20.89 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 8 - (Month 20); n=12 | -13.1 International unit per liter (IU/L) | Standard Deviation 29.03 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 9 - (Month 24); n=11 | -6.0 International unit per liter (IU/L) | Standard Deviation 29.25 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 10-(Month 28); n=10 | 8.3 International unit per liter (IU/L) | Standard Deviation 23.32 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 11-(Month 32); n=9 | 24.3 International unit per liter (IU/L) | Standard Deviation 32.31 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; Visit 12-(Month 36); n=4 | 10.0 International unit per liter (IU/L) | Standard Deviation 27.48 |
| RTG IR | Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (Alk. Phosph.), Aspartate Aminotransferase (AST), Creatine Kinase (CK), Gamma Glutamyl Transferase (GGT) and Lactate Dehydrogenase (LD) | GGT; StudyConclusion/Withdrawal; n=27 | 2.1 International unit per liter (IU/L) | Standard Deviation 33.39 |
Primary
Change From Baseline in Albumin and Total Protein
Blood samples were collected from participants to evaluate change from Baseline in albumin and total protein. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 1-Day 1; n=28 | -0.9 G/L | Standard Deviation 2.03 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 2 - Month 1; n=27 | -0.3 G/L | Standard Deviation 2.22 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 3 - Month 3; n=24 | -0.3 G/L | Standard Deviation 1.85 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 4 - Month 6; n=19 | 0.1 G/L | Standard Deviation 2.41 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 5 - Month 9; n=17 | -0.3 G/L | Standard Deviation 2.34 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 6 - Month 12; n=15 | -1.1 G/L | Standard Deviation 3.02 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 7-(Month 16); n=14 | -0.7 G/L | Standard Deviation 2.97 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 8 - (Month 20); n=12 | -0.6 G/L | Standard Deviation 2.02 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 9 - (Month 24); n=11 | -0.3 G/L | Standard Deviation 2.33 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 10-(Month 28); n=10 | -0.2 G/L | Standard Deviation 2.66 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 11-(Month 32); n=9 | 1.2 G/L | Standard Deviation 3.77 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Visit 12-(Month 36); n=4 | -0.3 G/L | Standard Deviation 0.96 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Study Conclusion/Withdrawal; n=27 | -0.6 G/L | Standard Deviation 2.48 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Albumin; Follow-Up Visit; n=4 | -0.3 G/L | Standard Deviation 2.87 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 1-Day 1; n=28 | -0.7 G/L | Standard Deviation 2.84 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 2 - Month 1; n=27 | -0.7 G/L | Standard Deviation 4.08 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 3 - Month 3; n=24 | 0.1 G/L | Standard Deviation 3.35 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 4 - Month 6; n=19 | 0.5 G/L | Standard Deviation 3.66 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 5 - Month 9; n=17 | -0.4 G/L | Standard Deviation 3.87 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 6 - Month 12; n=15 | -0.3 G/L | Standard Deviation 5.23 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 7-(Month 16); n=14 | 0.6 G/L | Standard Deviation 5.36 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 8 - (Month 20); n=12 | 1.3 G/L | Standard Deviation 4.41 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 9 - (Month 24); n=11 | 2.4 G/L | Standard Deviation 4.37 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 10-(Month 28); n=10 | 2.5 G/L | Standard Deviation 4.86 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 11-(Month 32); n=9 | 3.8 G/L | Standard Deviation 6.63 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Visit 12-(Month 36); n=4 | 1.8 G/L | Standard Deviation 2.22 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Study Conclusion/Withdrawal; n=27 | 0.7 G/L | Standard Deviation 3.52 |
| RTG IR | Change From Baseline in Albumin and Total Protein | Total protein; Follow-Up Visit; n=4 | 0.5 G/L | Standard Deviation 3 |
Primary
Change From Baseline in American Urological Association (AUA) Symptom Scale Scores
The effect of RTG on bladder function was assessed using AUA symptom index. It is a 7-item Likert-scored scale with seven questions, each with six potential responses. Responses to each of 7 questions were scored from 0 (no symptom at all) to 5 (almost always symptoms present) which were summmed to get total possible score ranging from 0 to 35 with higher scores indicating worse symptom severity. The total score for all questions was classified as mild (0-7), moderate (8-19) or severe (\>19). Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 1-Day 1; n=29 | -0.5 Scores on a scale | Standard Deviation 2.68 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 2-Month 1; n=28 | 0.3 Scores on a scale | Standard Deviation 2.37 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 3 - Month 3; n=25 | -0.3 Scores on a scale | Standard Deviation 2.41 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 6 - Month 12; n=15 | -0.7 Scores on a scale | Standard Deviation 1.58 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 7-(Month 16); n=1 | -2.0 Scores on a scale | — |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 9 - (Month 24); n=10 | -0.1 Scores on a scale | Standard Deviation 5.2 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 12-(Month 36); n=4 | 3.0 Scores on a scale | Standard Deviation 5.48 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Visit 13 (Month 40); n=1 | 0.0 Scores on a scale | — |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Study Conclusion/Withdrawal;n=29 | 1.1 Scores on a scale | Standard Deviation 4.45 |
| RTG IR | Change From Baseline in American Urological Association (AUA) Symptom Scale Scores | Follow-Up Visit; n=5 | 1.2 Scores on a scale | Standard Deviation 3.56 |
Primary
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC)
Blood samples were collected from participants for evaluation of change from Baseline in hematology parameters including basophils, eosinophils, lymphocytes,monocytes, platelet count, total neutrophils, and WBC. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and standard deviation (SD) were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 1-Day 1;n=29 | 0.000 Giga unit per liter (GI/L) | Standard Deviation 0.0118 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 2 - Month 1;n=28 | 0.000 Giga unit per liter (GI/L) | Standard Deviation 0.0126 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 3 - Month 3;n=26 | 0.000 Giga unit per liter (GI/L) | Standard Deviation 0.0118 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 4 - Month 6;n=16 | -0.003 Giga unit per liter (GI/L) | Standard Deviation 0.0184 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 5 - Month 9;n=16 | 0.001 Giga unit per liter (GI/L) | Standard Deviation 0.0178 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 6 - Month 12;n=13 | 0.003 Giga unit per liter (GI/L) | Standard Deviation 0.0132 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 7 (Month 16);n=12 | -0.002 Giga unit per liter (GI/L) | Standard Deviation 0.0147 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 8 (Month 20);n=11 | 0.003 Giga unit per liter (GI/L) | Standard Deviation 0.022 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 9 (Month 24);n=10 | 0.000 Giga unit per liter (GI/L) | Standard Deviation 0.0105 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 10 (Month 28);n=10 | 0.002 Giga unit per liter (GI/L) | Standard Deviation 0.0079 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 11 (Month 32);n=9 | 0.004 Giga unit per liter (GI/L) | Standard Deviation 0.0188 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Visit 12 (Month 36);n=4 | 0.005 Giga unit per liter (GI/L) | Standard Deviation 0.0058 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Study Conclusion/Withdrawal;n=28 | -0.003 Giga unit per liter (GI/L) | Standard Deviation 0.0146 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Basophils;Follow-Up Visit;n=5 | -0.008 Giga unit per liter (GI/L) | Standard Deviation 0.013 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils;Visit 1-Day 1; n=29 | -0.012 Giga unit per liter (GI/L) | Standard Deviation 0.1152 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 2 - Month 1; n=28 | -0.051 Giga unit per liter (GI/L) | Standard Deviation 0.1311 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 3 - Month 3; n=26 | -0.070 Giga unit per liter (GI/L) | Standard Deviation 0.2813 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 4 - Month 6; n=16 | -0.004 Giga unit per liter (GI/L) | Standard Deviation 0.102 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 5 - Month 9; n=16 | 0.038 Giga unit per liter (GI/L) | Standard Deviation 0.1038 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 6 - Month 12; n=13 | -0.014 Giga unit per liter (GI/L) | Standard Deviation 0.0846 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 7 (Month 16); n=12 | 0.010 Giga unit per liter (GI/L) | Standard Deviation 0.1135 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 8 (Month 20); n=11 | 0.008 Giga unit per liter (GI/L) | Standard Deviation 0.0908 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 9 (Month 24); n=10 | -0.051 Giga unit per liter (GI/L) | Standard Deviation 0.0983 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 10 (Month 28); n=10 | 0.006 Giga unit per liter (GI/L) | Standard Deviation 0.1467 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 11 (Month 32); n=9 | 0.011 Giga unit per liter (GI/L) | Standard Deviation 0.0494 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Visit 12 (Month 36); n=4 | -0.025 Giga unit per liter (GI/L) | Standard Deviation 0.09 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Study Conclusion/Withdrawal; n=28 | -0.026 Giga unit per liter (GI/L) | Standard Deviation 0.1085 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Eosinophils; Follow-Up Visit; n=5 | -0.078 Giga unit per liter (GI/L) | Standard Deviation 0.1268 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 1-Day 1; n= 29 | -0.132 Giga unit per liter (GI/L) | Standard Deviation 0.5985 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 2 - Month 1; n=28 | -0.065 Giga unit per liter (GI/L) | Standard Deviation 0.5549 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 3 - Month 3; n=26 | -0.120 Giga unit per liter (GI/L) | Standard Deviation 0.4974 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 4 - Month 6; n=16 | 0.024 Giga unit per liter (GI/L) | Standard Deviation 0.374 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 5 - Month 9; n=16 | -0.032 Giga unit per liter (GI/L) | Standard Deviation 0.4358 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 6 - Month 12; n= 13 | -0.109 Giga unit per liter (GI/L) | Standard Deviation 0.3685 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 7 (Month 16); n=12 | 0.007 Giga unit per liter (GI/L) | Standard Deviation 0.3039 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 8 (Month 20); n=11 | -0.037 Giga unit per liter (GI/L) | Standard Deviation 0.325 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 9 (Month 24); n=10 | 0.052 Giga unit per liter (GI/L) | Standard Deviation 0.4157 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 10 (Month 28); n=10 | 0.108 Giga unit per liter (GI/L) | Standard Deviation 0.2986 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 11 (Month 32); n=9 | 0.022 Giga unit per liter (GI/L) | Standard Deviation 0.428 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Visit 12 (Month 36); n=4 | -0.268 Giga unit per liter (GI/L) | Standard Deviation 0.3096 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Study Conclusion/Withdrawal; n=28 | -0.068 Giga unit per liter (GI/L) | Standard Deviation 0.5778 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Lymphocytes; Follow-Up Visit; n=5 | -0.070 Giga unit per liter (GI/L) | Standard Deviation 0.3466 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 1-Day 1; n= 29 | -0.018 Giga unit per liter (GI/L) | Standard Deviation 0.1204 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 2 - Month 1; n=28 | -0.028 Giga unit per liter (GI/L) | Standard Deviation 0.1357 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 3 - Month 3; n=26 | -0.044 Giga unit per liter (GI/L) | Standard Deviation 0.135 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 4 - Month 6; n=16 | 0.033 Giga unit per liter (GI/L) | Standard Deviation 0.1445 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 5 - Month 9; n=16 | -0.042 Giga unit per liter (GI/L) | Standard Deviation 0.1348 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 6 - Month 12; n= 13 | 0.076 Giga unit per liter (GI/L) | Standard Deviation 0.1711 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 7 (Month 16); n=12 | -0.021 Giga unit per liter (GI/L) | Standard Deviation 0.1717 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 8 (Month 20); n=11 | 0.129 Giga unit per liter (GI/L) | Standard Deviation 0.1936 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 9 (Month 24); n=10 | -0.021 Giga unit per liter (GI/L) | Standard Deviation 0.1358 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 10 (Month 28); n=10 | -0.022 Giga unit per liter (GI/L) | Standard Deviation 0.1781 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 11 (Month 32); n=9 | 0.088 Giga unit per liter (GI/L) | Standard Deviation 0.1384 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Visit 12 (Month 36); n=4 | 0.035 Giga unit per liter (GI/L) | Standard Deviation 0.0823 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Study Conclusion/Withdrawal; n=28 | 0.014 Giga unit per liter (GI/L) | Standard Deviation 0.1809 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Monocytes; Follow-Up Visit; n=5 | 0.054 Giga unit per liter (GI/L) | Standard Deviation 0.1011 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 1-Day 1; n=28 | 8.3 Giga unit per liter (GI/L) | Standard Deviation 25.26 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 2 - Month 1; n=28 | 6.3 Giga unit per liter (GI/L) | Standard Deviation 24.01 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 3 - Month 3; n=25 | 14.5 Giga unit per liter (GI/L) | Standard Deviation 26.01 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 4 - Month 6; n=18 | 5.8 Giga unit per liter (GI/L) | Standard Deviation 37.84 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 5 - Month 9; n=17 | 6.0 Giga unit per liter (GI/L) | Standard Deviation 29.9 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 6 - Month 12; n=15 | 10.2 Giga unit per liter (GI/L) | Standard Deviation 35.51 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 7 (Month 16); n=14 | 18.5 Giga unit per liter (GI/L) | Standard Deviation 23.65 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 8 (Month 20); n=11 | 16.6 Giga unit per liter (GI/L) | Standard Deviation 39.64 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 9 (Month 24); n=11 | 15.5 Giga unit per liter (GI/L) | Standard Deviation 22.98 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 10 (Month 28); n=10 | 20.3 Giga unit per liter (GI/L) | Standard Deviation 40.66 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 11 (Month 32); n=9 | 17.1 Giga unit per liter (GI/L) | Standard Deviation 50.38 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Visit 12 (Month 36); n=4 | 28.5 Giga unit per liter (GI/L) | Standard Deviation 13.53 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Study Conclusion/Withdrawal; n=28 | 17.0 Giga unit per liter (GI/L) | Standard Deviation 37.37 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Platelet count; Follow-Up Visit; n=5 | -2.0 Giga unit per liter (GI/L) | Standard Deviation 26.93 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 1-Day 1; n=30 | -0.099 Giga unit per liter (GI/L) | Standard Deviation 1.345 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 2 - Month 1; n=28 | -0.028 Giga unit per liter (GI/L) | Standard Deviation 1.1045 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 3 - Month 3; n=26 | 0.369 Giga unit per liter (GI/L) | Standard Deviation 1.7061 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 4 - Month 6; n=16 | -0.318 Giga unit per liter (GI/L) | Standard Deviation 1.4286 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 5 - Month 9; n=16 | -0.158 Giga unit per liter (GI/L) | Standard Deviation 1.6801 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 6 - Month 12; n=13 | 0.182 Giga unit per liter (GI/L) | Standard Deviation 0.9911 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 7 (Month 16); n=12 | 0.252 Giga unit per liter (GI/L) | Standard Deviation 0.9079 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 8 (Month 20); n=11 | 0.325 Giga unit per liter (GI/L) | Standard Deviation 1.0561 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 9 (Month 24); n=10 | 0.656 Giga unit per liter (GI/L) | Standard Deviation 1.0269 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 10 (Month 28); n=10 | 0.238 Giga unit per liter (GI/L) | Standard Deviation 0.8603 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 11 (Month 32); n=9 | 1.310 Giga unit per liter (GI/L) | Standard Deviation 2.2464 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Visit 12 (Month 36); n=4 | 0.310 Giga unit per liter (GI/L) | Standard Deviation 0.68 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils;Study Conclusion/Withdrawal;n=28 | 0.086 Giga unit per liter (GI/L) | Standard Deviation 1.1378 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | Total Neutrophils; Follow-Up Visit; n=5 | -0.176 Giga unit per liter (GI/L) | Standard Deviation 1.4051 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC ; Visit 1-Day 1; n=30 | -0.15 Giga unit per liter (GI/L) | Standard Deviation 1.417 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC ; Visit 2 - Month 1; n=28 | -0.16 Giga unit per liter (GI/L) | Standard Deviation 1.182 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 3 - Month 3; n=26 | 0.14 Giga unit per liter (GI/L) | Standard Deviation 1.501 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 4 - Month 6; n=18 | -0.42 Giga unit per liter (GI/L) | Standard Deviation 1.545 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 5 - Month 9; n=17 | -0.12 Giga unit per liter (GI/L) | Standard Deviation 1.63 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 6 - Month 12; n=15 | 0.34 Giga unit per liter (GI/L) | Standard Deviation 1.33 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC ; Visit 7 (Month 16); n=14 | 0.20 Giga unit per liter (GI/L) | Standard Deviation 0.927 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC ; Visit 8 (Month 20); n=12 | 0.53 Giga unit per liter (GI/L) | Standard Deviation 1.127 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC ; Visit 9 (Month 24); n=11 | 0.64 Giga unit per liter (GI/L) | Standard Deviation 0.837 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 10 (Month 28); n=10 | 0.33 Giga unit per liter (GI/L) | Standard Deviation 1.003 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 11 (Month 32); n=9 | 1.43 Giga unit per liter (GI/L) | Standard Deviation 2.155 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Visit 12 (Month 36); n=4 | 0.08 Giga unit per liter (GI/L) | Standard Deviation 0.991 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Study Conclusion/Withdrawal;n=28 | 0.01 Giga unit per liter (GI/L) | Standard Deviation 1.212 |
| RTG IR | Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils, and White Blood Cell Count (WBC) | WBC; Follow-Up Visit; n=5 | -0.28 Giga unit per liter (GI/L) | Standard Deviation 1.395 |
Primary
Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio
Blood samples were collected from participants to evaluate change from Baseline in BUN/creatinine. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 1-Day 1; n=28 | 4.2 Ratio | Standard Deviation 21.83 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 2 - Month 1; n=27 | 6.2 Ratio | Standard Deviation 20.92 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 3 - Month 3; n=24 | 7.0 Ratio | Standard Deviation 22.03 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 4 - Month 6; n=19 | 7.0 Ratio | Standard Deviation 18.11 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 5 - Month 9; n=17 | 18.11 Ratio | Standard Deviation 16.4 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 6 - Month 12; n=15 | 5.5 Ratio | Standard Deviation 13.43 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 7-(Month 16); n=14 | 4.2 Ratio | Standard Deviation 24.49 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 8 - (Month 20); n=12 | 12.8 Ratio | Standard Deviation 21.46 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 9 - (Month 24); n=11 | 7.0 Ratio | Standard Deviation 16.25 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 10-(Month 28); n=10 | 1.9 Ratio | Standard Deviation 21.97 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 11-(Month 32); n=9 | 13.8 Ratio | Standard Deviation 25.29 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Visit 12-(Month 36); n=4 | 30.0 Ratio | Standard Deviation 24.04 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Study Conclusion/Withdrawal; n=27 | 3.1 Ratio | Standard Deviation 24.5 |
| RTG IR | Change From Baseline in Blood Urea Nitrogen (BUN)/Creatinine Ratio | Follow-Up Visit; n=4 | 1.0 Ratio | Standard Deviation 29.39 |
Primary
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN
Blood samples were collected from participants to evaluate change from Baseline in calcium, CO2 content/Bicarb, chloride, glucose, magnesium, potassium, sodium, and urea/BUN. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 9 - (Month 24); n=11 | 0.006 Millimoles per liter (mmol/L) | Standard Deviation 0.0543 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 10-(Month 28); n=9 | 0.012 Millimoles per liter (mmol/L) | Standard Deviation 0.0602 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 11-(Month 32); n=9 | 0.026 Millimoles per liter (mmol/L) | Standard Deviation 0.0915 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 12-(Month 36); n=4 | 0.013 Millimoles per liter (mmol/L) | Standard Deviation 0.0171 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; StudyConclusion/Withdrawal; n=27 | 0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.082 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Follow-Up Visit; n=4 | 0.068 Millimoles per liter (mmol/L) | Standard Deviation 0.0634 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 1-Day 1; n=27 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.11 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 2 - Month 1; n=26 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.94 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 1-Day 1; n=27 | -0.015 Millimoles per liter (mmol/L) | Standard Deviation 0.0759 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 2 - Month 1; n=26 | -0.009 Millimoles per liter (mmol/L) | Standard Deviation 0.0813 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 3 - Month 3; n=24 | 0.017 Millimoles per liter (mmol/L) | Standard Deviation 0.0586 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 4 - Month 6; n=19 | 0.009 Millimoles per liter (mmol/L) | Standard Deviation 0.0819 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 5 - Month 9; n=17 | 0.020 Millimoles per liter (mmol/L) | Standard Deviation 0.0742 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 6 - Month 12; n=15 | -0.013 Millimoles per liter (mmol/L) | Standard Deviation 0.0786 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 7-(Month 16); n=14 | 0.009 Millimoles per liter (mmol/L) | Standard Deviation 0.0809 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Calcium; Visit 8 - (Month 20); n=12 | 0.013 Millimoles per liter (mmol/L) | Standard Deviation 0.0628 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 3 - Month 3; n=24 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 3.52 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 4 - Month 6; n=19 | -0.6 Millimoles per liter (mmol/L) | Standard Deviation 2.8 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 5 - Month 9; n=17 | -0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.7 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 6 - Month 12; n=15 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 1.44 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 7-(Month 16); n=14 | -0.1 Millimoles per liter (mmol/L) | Standard Deviation 2.59 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 8 - (Month 20); n=12 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 1.96 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 9 - (Month 24); n=11 | -1.5 Millimoles per liter (mmol/L) | Standard Deviation 2.58 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 10-(Month 28); n=9 | -1.8 Millimoles per liter (mmol/L) | Standard Deviation 1.39 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 11-(Month 32); n=9 | 2.4 Millimoles per liter (mmol/L) | Standard Deviation 1.94 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Visit 12-(Month 36); n=4 | -1.5 Millimoles per liter (mmol/L) | Standard Deviation 1.91 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2content/Bicarb;Study Conclusion/Withdrawal;n=27 | -1.0 Millimoles per liter (mmol/L) | Standard Deviation 2.72 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | CO2 content/Bicarb; Follow-Up Visit; n=4 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 1-Day 1; n=28 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 2.97 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 2 - Month 1; n=27 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 3.32 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 3 - Month 3; n=24 | -0.2 Millimoles per liter (mmol/L) | Standard Deviation 2.91 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 4 - Month 6; n=19 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.89 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 5 - Month 9; n=17 | 0.1 Millimoles per liter (mmol/L) | Standard Deviation 3.22 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 6 - Month 12; n=15 | 0.6 Millimoles per liter (mmol/L) | Standard Deviation 3.54 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 7-(Month 16); n=14 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.73 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 8 - (Month 20); n=12 | 1.3 Millimoles per liter (mmol/L) | Standard Deviation 3.7 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 9 - (Month 24); n=11 | 1.0 Millimoles per liter (mmol/L) | Standard Deviation 3.32 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 10-(Month 28); n=10 | 0.9 Millimoles per liter (mmol/L) | Standard Deviation 3.87 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 11-(Month 32); n=9 | 1.3 Millimoles per liter (mmol/L) | Standard Deviation 5.32 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Visit 12-(Month 36); n=4 | -1.5 Millimoles per liter (mmol/L) | Standard Deviation 3.87 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; StudyConclusion/Withdrawal;n=27 | -0.4 Millimoles per liter (mmol/L) | Standard Deviation 3.67 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Chloride; Follow-Up Visit; n=4 | -0.8 Millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 1-Day 1; n=28 | -0.42 Millimoles per liter (mmol/L) | Standard Deviation 1.458 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 2 - Month 1; n=27 | 0.13 Millimoles per liter (mmol/L) | Standard Deviation 1.554 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 3 - Month 3; n=24 | 0.12 Millimoles per liter (mmol/L) | Standard Deviation 1.426 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 4 - Month 6; n=19 | 0.55 Millimoles per liter (mmol/L) | Standard Deviation 1.094 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 5 - Month 9; n=17 | 0.32 Millimoles per liter (mmol/L) | Standard Deviation 1.709 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 6 - Month 12; n=15 | 0.05 Millimoles per liter (mmol/L) | Standard Deviation 1.477 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 7-(Month 16); n=14 | 1.97 Millimoles per liter (mmol/L) | Standard Deviation 6.817 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 8 - (Month 20); n=12 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 1.298 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 9 - (Month 24); n=11 | 0.49 Millimoles per liter (mmol/L) | Standard Deviation 1.713 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 10-(Month 28); n=10 | 1.14 Millimoles per liter (mmol/L) | Standard Deviation 2.303 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 11-(Month 32); n=9 | 1.13 Millimoles per liter (mmol/L) | Standard Deviation 0.892 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Visit 12-(Month 36); n=4 | 1.75 Millimoles per liter (mmol/L) | Standard Deviation 2.533 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; StudyConclusion/Withdrawal;n=27 | 0.72 Millimoles per liter (mmol/L) | Standard Deviation 2.312 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Glucose; Follow-Up Visit; n=4 | -0.30 Millimoles per liter (mmol/L) | Standard Deviation 1.152 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 1-Day 1; n=28 | -0.004 Millimoles per liter (mmol/L) | Standard Deviation 0.0522 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 2 - Month 1; n=27 | -0.017 Millimoles per liter (mmol/L) | Standard Deviation 0.0716 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 3 - Month 3; n=24 | -0.019 Millimoles per liter (mmol/L) | Standard Deviation 0.0733 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 4 - Month 6; n=19 | -0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.0565 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 5 - Month 9; n=17 | 0.006 Millimoles per liter (mmol/L) | Standard Deviation 0.0662 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 6 - Month 12; n=15 | 0.027 Millimoles per liter (mmol/L) | Standard Deviation 0.064 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 7-(Month 16); n=14 | 0.041 Millimoles per liter (mmol/L) | Standard Deviation 0.0434 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 8 - (Month 20); n=12 | 0.040 Millimoles per liter (mmol/L) | Standard Deviation 0.0628 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 9 - (Month 24); n=11 | 0.035 Millimoles per liter (mmol/L) | Standard Deviation 0.052 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 10-(Month 28); n=10 | 0.058 Millimoles per liter (mmol/L) | Standard Deviation 0.0692 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 11-(Month 32); n=9 | 0.050 Millimoles per liter (mmol/L) | Standard Deviation 0.0585 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Visit 12-(Month 36); n=4 | 0.020 Millimoles per liter (mmol/L) | Standard Deviation 0.0606 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Study Conclusion/Withdrawal;n=27 | 0.016 Millimoles per liter (mmol/L) | Standard Deviation 0.0582 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Magnesium; Follow-Up Visit; n=4 | 0.053 Millimoles per liter (mmol/L) | Standard Deviation 0.1424 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 1-Day 1; n=27 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.277 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 2 - Month 1; n=26 | -0.05 Millimoles per liter (mmol/L) | Standard Deviation 0.258 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 3 - Month 3; n=24 | 0.00 Millimoles per liter (mmol/L) | Standard Deviation 0.227 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 4 - Month 6; n=19 | 0.07 Millimoles per liter (mmol/L) | Standard Deviation 0.341 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 5 - Month 9; n=17 | 0.01 Millimoles per liter (mmol/L) | Standard Deviation 0.398 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 6 - Month 12; n=15 | 0.10 Millimoles per liter (mmol/L) | Standard Deviation 0.321 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 7-(Month 16); n=14 | 0.06 Millimoles per liter (mmol/L) | Standard Deviation 0.247 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 8 - (Month 20); n=12 | 0.09 Millimoles per liter (mmol/L) | Standard Deviation 0.215 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 9 - (Month 24); n=11 | 0.08 Millimoles per liter (mmol/L) | Standard Deviation 0.264 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 10-(Month 28); n=9 | 0.21 Millimoles per liter (mmol/L) | Standard Deviation 0.318 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 11-(Month 32); n=9 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.367 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Visit 12-(Month 36); n=4 | 0.18 Millimoles per liter (mmol/L) | Standard Deviation 0.222 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Study Conclusion/Withdrawal;n=27 | -0.02 Millimoles per liter (mmol/L) | Standard Deviation 0.275 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Potassium; Follow-Up Visit; n=4 | 0.20 Millimoles per liter (mmol/L) | Standard Deviation 0.163 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 1-Day 1; n=28 | -0.9 Millimoles per liter (mmol/L) | Standard Deviation 3.37 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 2 - Month 1; n=27 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 3.48 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 3 - Month 3; n=24 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 3 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 4 - Month 6; n=19 | -0.3 Millimoles per liter (mmol/L) | Standard Deviation 2.79 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 5 - Month 9; n=17 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 2.52 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 6 - Month 12; n=15 | 0.7 Millimoles per liter (mmol/L) | Standard Deviation 3.58 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 7-(Month 16); n=14 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 4.21 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 8 - (Month 20); n=12 | 0.8 Millimoles per liter (mmol/L) | Standard Deviation 4.13 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 9 - (Month 24); n=11 | 1.1 Millimoles per liter (mmol/L) | Standard Deviation 2.07 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 10-(Month 28); n=10 | 1.3 Millimoles per liter (mmol/L) | Standard Deviation 3.53 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 11-(Month 32); n=9 | 1.2 Millimoles per liter (mmol/L) | Standard Deviation 4.74 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Visit 12-(Month 36); n=4 | -2.0 Millimoles per liter (mmol/L) | Standard Deviation 4.76 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; StudyConclusion/Withdrawal;n=27 | 0.2 Millimoles per liter (mmol/L) | Standard Deviation 3.14 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Sodium; Follow-Up Visit; n=4 | 0.5 Millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 1-Day 1; n=28 | 0.14 Millimoles per liter (mmol/L) | Standard Deviation 1.176 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 2 - Month 1; n=27 | 0.36 Millimoles per liter (mmol/L) | Standard Deviation 1.239 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 3 - Month 3; n=24 | 0.46 Millimoles per liter (mmol/L) | Standard Deviation 1.353 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 4 - Month 6; n=19 | 0.37 Millimoles per liter (mmol/L) | Standard Deviation 1.18 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 5 - Month 9; n=17 | 0.62 Millimoles per liter (mmol/L) | Standard Deviation 0.884 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 6 - Month 12; n=15 | 0.51 Millimoles per liter (mmol/L) | Standard Deviation 0.877 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 7-(Month 16); n=14 | 0.25 Millimoles per liter (mmol/L) | Standard Deviation 1.26 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 8 - (Month 20); n=12 | 0.91 Millimoles per liter (mmol/L) | Standard Deviation 1.372 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 9 - (Month 24); n=11 | 0.46 Millimoles per liter (mmol/L) | Standard Deviation 1.016 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 10-(Month 28); n=10 | 0.39 Millimoles per liter (mmol/L) | Standard Deviation 1.325 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 11-(Month 32); n=9 | 0.77 Millimoles per liter (mmol/L) | Standard Deviation 1.578 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Visit 12-(Month 36); n=4 | 1.90 Millimoles per liter (mmol/L) | Standard Deviation 1.971 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Study Conclusion/Withdrawal;n=27 | 0.18 Millimoles per liter (mmol/L) | Standard Deviation 1.409 |
| RTG IR | Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate (Bicarb), Chloride, Glucose, Magnesium, Potassium, Sodium, Urea/BUN | Urea/BUN; Follow-Up Visit; n=4 | 0.25 Millimoles per liter (mmol/L) | Standard Deviation 1.287 |
Primary
Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid
Blood samples were collected from participants to evaluate change from Baseline in creatinine, direct bilirubin, total bilirubin, and uric acid. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 1-Day 1; n=28 | -2.18 Micromoles per liter (µmol/L) | Standard Deviation 5.86 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 2 - Month 1; n=27 | -0.79 Micromoles per liter (µmol/L) | Standard Deviation 6.45 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 3 - Month 3; n=24 | -0.35 Micromoles per liter (µmol/L) | Standard Deviation 5.36 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 4 - Month 6; n=19 | -1.39 Micromoles per liter (µmol/L) | Standard Deviation 6.575 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 5 - Month 9; n=17 | 0.32 Micromoles per liter (µmol/L) | Standard Deviation 4.77 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 6 - Month 12; n=15 | 0.61 Micromoles per liter (µmol/L) | Standard Deviation 4.837 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 7-(Month 16); n=14 | -0.94 Micromoles per liter (µmol/L) | Standard Deviation 6.951 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 8 - (Month 20); n=12 | -0.05 Micromoles per liter (µmol/L) | Standard Deviation 5.97 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 9 - (Month 24); n=11 | -0.15 Micromoles per liter (µmol/L) | Standard Deviation 5.095 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 10-(Month 28); n=10 | 4.31 Micromoles per liter (µmol/L) | Standard Deviation 8.665 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 11-(Month 32); n=9 | -3.30 Micromoles per liter (µmol/L) | Standard Deviation 4.268 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Visit 12-(Month 36); n=4 | -2.73 Micromoles per liter (µmol/L) | Standard Deviation 11.099 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Study Conclusion/Withdrawal;n=27 | -0.08 Micromoles per liter (µmol/L) | Standard Deviation 5.467 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Creatinine; Follow-Up Visit; n=4 | 4.30 Micromoles per liter (µmol/L) | Standard Deviation 20.628 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 1-Day 1; n=28 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.67 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 2 - Month 1; n=27 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0.65 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 3 - Month 3; n=24 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0.46 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 4 - Month 6; n=19 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0.58 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 5 - Month 9; n=17 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.64 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 6 - Month 12; n=15 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.35 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 7-(Month 16); n=14 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.53 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 8 - (Month 20); n=12 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.51 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 9 - (Month 24); n=11 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.75 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 10-(Month 28); n=10 | -0.1 Micromoles per liter (µmol/L) | Standard Deviation 0.32 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 11-(Month 32); n=9 | -0.2 Micromoles per liter (µmol/L) | Standard Deviation 0.44 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Visit 12-(Month 36); n=4 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0.82 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Study Conclusion/Withdrawal;n=27 | 0.0 Micromoles per liter (µmol/L) | Standard Deviation 0.59 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Direct Bilirubin; Follow-Up Visit; n=4 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 1.26 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 1-Day 1; n=28 | 3.0 Micromoles per liter (µmol/L) | Standard Deviation 2.57 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 2 - Month 1; n=27 | 3.7 Micromoles per liter (µmol/L) | Standard Deviation 2.69 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 3 - Month 3; n=24 | 3.8 Micromoles per liter (µmol/L) | Standard Deviation 2.14 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 4 - Month 6; n=19 | 3.7 Micromoles per liter (µmol/L) | Standard Deviation 2.87 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 5 - Month 9; n=17 | 2.8 Micromoles per liter (µmol/L) | Standard Deviation 1.85 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 6 - Month 12; n=15 | 3.1 Micromoles per liter (µmol/L) | Standard Deviation 3.03 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 7-(Month 16); n=14 | 3.5 Micromoles per liter (µmol/L) | Standard Deviation 1.65 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 8 - (Month 20); n=12 | 2.8 Micromoles per liter (µmol/L) | Standard Deviation 1.9 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 9 - (Month 24); n=11 | 2.7 Micromoles per liter (µmol/L) | Standard Deviation 1.95 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 10-(Month 28); n=10 | 3.0 Micromoles per liter (µmol/L) | Standard Deviation 2.11 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 11-(Month 32); n=9 | 2.6 Micromoles per liter (µmol/L) | Standard Deviation 1.51 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Visit 12-(Month 36); n=4 | 4.5 Micromoles per liter (µmol/L) | Standard Deviation 2.65 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Study Conclusion/Withdrawal;n=27 | 2.9 Micromoles per liter (µmol/L) | Standard Deviation 2.83 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Total Bilirubin; Follow-Up Visit; n=4 | 2.3 Micromoles per liter (µmol/L) | Standard Deviation 4.99 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 1-Day 1; n=28 | -0.6 Micromoles per liter (µmol/L) | Standard Deviation 31.72 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 2 - Month 1; n=27 | 6.3 Micromoles per liter (µmol/L) | Standard Deviation 33.86 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 3 - Month 3; n=24 | -5.8 Micromoles per liter (µmol/L) | Standard Deviation 31.63 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 4 - Month 6; n=19 | 0.3 Micromoles per liter (µmol/L) | Standard Deviation 32.18 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 5 - Month 9; n=17 | 4.3 Micromoles per liter (µmol/L) | Standard Deviation 25.3 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 6 - Month 12; n=15 | -5.5 Micromoles per liter (µmol/L) | Standard Deviation 38.81 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 7-(Month 16); n=14 | -15.0 Micromoles per liter (µmol/L) | Standard Deviation 51.93 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 8 - (Month 20); n=12 | -10.5 Micromoles per liter (µmol/L) | Standard Deviation 45.12 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 9 - (Month 24); n=11 | 8.6 Micromoles per liter (µmol/L) | Standard Deviation 51.81 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 10-(Month 28); n=10 | 6.3 Micromoles per liter (µmol/L) | Standard Deviation 64.91 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 11-(Month 32); n=9 | -5.2 Micromoles per liter (µmol/L) | Standard Deviation 66.94 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Visit 12-(Month 36); n=4 | -30.3 Micromoles per liter (µmol/L) | Standard Deviation 46.5 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Study Conclusion/Withdrawal;n=26 | 9.7 Micromoles per liter (µmol/L) | Standard Deviation 46.87 |
| RTG IR | Change From Baseline in Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid | Uric acid; Follow-Up Visit; n=4 | 15.8 Micromoles per liter (µmol/L) | Standard Deviation 62.74 |
Primary
Change From Baseline in Hematocrit
Blood samples were collected from participants for evaluation of hematocrit. Hematocrit is a ratio of red blood cells to the total volume of blood. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Hematocrit | Visit 1-Day 1; n=30 | -0.0035 Proportion of red blood cells in blood | Standard Deviation 0.02749 |
| RTG IR | Change From Baseline in Hematocrit | Visit 2 - Month 1; n=28 | -0.0048 Proportion of red blood cells in blood | Standard Deviation 0.02512 |
| RTG IR | Change From Baseline in Hematocrit | Visit 3 - Month 3; n=26 | -0.0033 Proportion of red blood cells in blood | Standard Deviation 0.02175 |
| RTG IR | Change From Baseline in Hematocrit | Visit 4 - Month 6; n=18 | -0.0022 Proportion of red blood cells in blood | Standard Deviation 0.01659 |
| RTG IR | Change From Baseline in Hematocrit | Visit 5 - Month 9; n=17 | -0.0004 Proportion of red blood cells in blood | Standard Deviation 0.0179 |
| RTG IR | Change From Baseline in Hematocrit | Visit 6 - Month 12; n=15 | -0.0014 Proportion of red blood cells in blood | Standard Deviation 0.01883 |
| RTG IR | Change From Baseline in Hematocrit | Visit 7 (Month 16); n=14 | 0.0027 Proportion of red blood cells in blood | Standard Deviation 0.01887 |
| RTG IR | Change From Baseline in Hematocrit | Visit 8 (Month 20); n=12 | 0.0105 Proportion of red blood cells in blood | Standard Deviation 0.01857 |
| RTG IR | Change From Baseline in Hematocrit | Visit 9 (Month 24); n=11 | 0.0174 Proportion of red blood cells in blood | Standard Deviation 0.02331 |
| RTG IR | Change From Baseline in Hematocrit | Visit 10 (Month 28); n=10 | 0.0189 Proportion of red blood cells in blood | Standard Deviation 0.01987 |
| RTG IR | Change From Baseline in Hematocrit | Visit 11 (Month 32); n=9 | 0.0344 Proportion of red blood cells in blood | Standard Deviation 0.02959 |
| RTG IR | Change From Baseline in Hematocrit | Visit 12 (Month 36); n=4 | 0.0408 Proportion of red blood cells in blood | Standard Deviation 0.02608 |
| RTG IR | Change From Baseline in Hematocrit | Study Conclusion/Withdrawal;n=28 | 0.0055 Proportion of red blood cells in blood | Standard Deviation 0.02345 |
| RTG IR | Change From Baseline in Hematocrit | Follow-Up Visit; n=5 | 0.0048 Proportion of red blood cells in blood | Standard Deviation 0.021 |
Primary
Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
Blood samples were collected from participants to evaluate change from Baseline in hemoglobin and MCHC levels. Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 1-Day 1; n=30 | -2.6 Gram per Liter (G/L) | Standard Deviation 8.23 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 2 - Month 1; n=28 | -2.8 Gram per Liter (G/L) | Standard Deviation 7.75 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 3 - Month 3; n=26 | -2.2 Gram per Liter (G/L) | Standard Deviation 6.83 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 4 - Month 6; n=18 | -0.2 Gram per Liter (G/L) | Standard Deviation 5.33 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 5 - Month 9; n=17 | -0.8 Gram per Liter (G/L) | Standard Deviation 5.96 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 6 - Month 12; n=15 | -1.9 Gram per Liter (G/L) | Standard Deviation 6.28 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 7 (Month 16); n=14 | -1.5 Gram per Liter (G/L) | Standard Deviation 6 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 8 (Month 20); n=12 | 2.3 Gram per Liter (G/L) | Standard Deviation 5.1 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 9 (Month 24); n=11 | 2.6 Gram per Liter (G/L) | Standard Deviation 6.55 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 10 (Month 28); n=10 | 1.9 Gram per Liter (G/L) | Standard Deviation 6.12 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 11 (Month 32); n=9 | 9.1 Gram per Liter (G/L) | Standard Deviation 9.84 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Visit 12 (Month 36); n=4 | 8.0 Gram per Liter (G/L) | Standard Deviation 6.98 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Study Conclusion/Withdrawal;n=28 | 1.3 Gram per Liter (G/L) | Standard Deviation 6.31 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | Hemoglobin; Follow-Up Visit; n=5 | 1.8 Gram per Liter (G/L) | Standard Deviation 7.92 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 1-Day 1; n=30 | -3.1 Gram per Liter (G/L) | Standard Deviation 8.45 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 2 - Month 1; n=28 | -2.9 Gram per Liter (G/L) | Standard Deviation 7.92 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 3 - Month 3; n=26 | -2.4 Gram per Liter (G/L) | Standard Deviation 9.27 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 4 - Month 6; n=18 | 1.2 Gram per Liter (G/L) | Standard Deviation 7.31 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 5 - Month 9; n=17 | -1.1 Gram per Liter (G/L) | Standard Deviation 4.61 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 6 - Month 12; n=15 | -2.6 Gram per Liter (G/L) | Standard Deviation 7.21 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 7 (Month 16); n=14 | -5.1 Gram per Liter (G/L) | Standard Deviation 9.63 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 8 (Month 20); n=12 | -2.3 Gram per Liter (G/L) | Standard Deviation 7.8 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 9 (Month 24); n=11 | -6.4 Gram per Liter (G/L) | Standard Deviation 8.56 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 10 (Month 28); n=10 | -9.9 Gram per Liter (G/L) | Standard Deviation 8.24 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 11 (Month 32); n=9 | -4.6 Gram per Liter (G/L) | Standard Deviation 6.31 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Visit 12 (Month 36); n=4 | -12.8 Gram per Liter (G/L) | Standard Deviation 4.19 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; StudyConclusion/Withdrawal;n=28 | -1.3 Gram per Liter (G/L) | Standard Deviation 8.47 |
| RTG IR | Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) | MCHC; Follow-Up Visit; n=5 | 0.8 Gram per Liter (G/L) | Standard Deviation 10.43 |
Primary
Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level
Blood samples were collected from participants to evaluate change from Baseline in MCH levels. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 5 - Month 9; n=17 | -0.46 Picogram (Pg) | Standard Deviation 0.6 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 1-Day 1; n=30 | -0.30 Picogram (Pg) | Standard Deviation 0.539 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 2 - Month 1; n=28 | -0.16 Picogram (Pg) | Standard Deviation 0.807 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 3 - Month 3; n=26 | -0.23 Picogram (Pg) | Standard Deviation 0.759 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 4 - Month 6; n=18 | -0.14 Picogram (Pg) | Standard Deviation 0.731 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 6 - Month 12; n=15 | -0.65 Picogram (Pg) | Standard Deviation 0.588 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 7 (Month 16); n=14 | -0.56 Picogram (Pg) | Standard Deviation 0.717 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 8 (Month 20); n=12 | -0.73 Picogram (Pg) | Standard Deviation 0.574 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 9 (Month 24); n=11 | -0.87 Picogram (Pg) | Standard Deviation 0.461 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 10 (Month 28); n=10 | -0.76 Picogram (Pg) | Standard Deviation 0.435 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 11 (Month 32); n=9 | -0.73 Picogram (Pg) | Standard Deviation 0.391 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Visit 12 (Month 36); n=4 | -1.53 Picogram (Pg) | Standard Deviation 0.506 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | StudyConclusion/Withdrawal; n=28 | -0.52 Picogram (Pg) | Standard Deviation 0.731 |
| RTG IR | Change From Baseline in Mean Corpuscle Hemoglobin (MCH) Level | Follow-Up Visit; n=5 | -0.64 Picogram (Pg) | Standard Deviation 0.611 |
Primary
Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV)
Blood samples were collected from participants to evaluate change from Baseline in MCV and MPV levels. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 1-Day 1; n=30 | 0.1 Femtoliter (fL) | Standard Deviation 2.15 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 2 - Month 1; n=28 | 0.4 Femtoliter (fL) | Standard Deviation 2.35 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 3 - Month 3; n=26 | 0.1 Femtoliter (fL) | Standard Deviation 2.42 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 4 - Month 6; n=18 | -0.7 Femtoliter (fL) | Standard Deviation 1.75 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 5 - Month 9; n=17 | -1.1 Femtoliter (fL) | Standard Deviation 1.52 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 6 - Month 12; n=15 | -1.2 Femtoliter (fL) | Standard Deviation 2.08 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 7-(Month 16); n=14 | -0.1 Femtoliter (fL) | Standard Deviation 2.06 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 8-(Month 20); n=12 | -1.3 Femtoliter (fL) | Standard Deviation 2.01 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 9-(Month 24); n=11 | -0.7 Femtoliter (fL) | Standard Deviation 1.85 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 10-(Month 28); n=10 | 0.8 Femtoliter (fL) | Standard Deviation 2.44 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 1- (Month 32); n=9 | -0.8 Femtoliter (fL) | Standard Deviation 2.05 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Visit 12- (Month 36); n=4 | -0.8 Femtoliter (fL) | Standard Deviation 1.26 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; StudyConclusion/Withdrawal; n=28 | -1.0 Femtoliter (fL) | Standard Deviation 2.16 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MCV; Follow-Up Visit; n=5 | -2.2 Femtoliter (fL) | Standard Deviation 1.64 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 1- Day 1; n=28 | -0.43 Femtoliter (fL) | Standard Deviation 0.526 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 2 - Month 1; n=28 | -0.41 Femtoliter (fL) | Standard Deviation 0.61 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 3 - Month 3; n=25 | -0.34 Femtoliter (fL) | Standard Deviation 0.579 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 4 - Month 6; n=18 | -0.07 Femtoliter (fL) | Standard Deviation 0.642 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 5 - Month 9; n=17 | -0.32 Femtoliter (fL) | Standard Deviation 0.645 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 6 - Month 12; n=15 | -0.19 Femtoliter (fL) | Standard Deviation 0.678 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 7-(Month 16); n=14 | -0.36 Femtoliter (fL) | Standard Deviation 0.624 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 8-(Month 20); n=11 | -0.15 Femtoliter (fL) | Standard Deviation 0.658 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 9-(Month 24); n=11 | 0.07 Femtoliter (fL) | Standard Deviation 0.629 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 10-(Month 28); n=10 | -0.14 Femtoliter (fL) | Standard Deviation 0.435 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 11- (Month 32); n=9 | 0.21 Femtoliter (fL) | Standard Deviation 0.933 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Visit 12- (Month 36); n=4 | -0.73 Femtoliter (fL) | Standard Deviation 0.386 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; StudyConclusion/Withdrawal; n=28 | -0.18 Femtoliter (fL) | Standard Deviation 0.572 |
| RTG IR | Change From Baseline in Mean Corpuscle Volume (MCV) and Mean Platelet Volume (MPV) | MPV; Follow-Up Visit; n=5 | 0.28 Femtoliter (fL) | Standard Deviation 0.349 |
Primary
Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes
The PVR bladder ultrasound was used to assess the effects of RTG on bladder function. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 1-Day 1; n=29 | -3.4 Milliliter (mL) | Standard Deviation 36.38 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 2 - Month 1; n=28 | 9.2 Milliliter (mL) | Standard Deviation 24.66 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 3 - Month 3; n=25 | 2.0 Milliliter (mL) | Standard Deviation 39.72 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 6 - Month 12; n=15 | 1.7 Milliliter (mL) | Standard Deviation 30.67 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 7-(Month 16); n=1 | -8.0 Milliliter (mL) | — |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 9 - (Month 24); n=10 | -8.2 Milliliter (mL) | Standard Deviation 36.79 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 12-(Month 36); n=4 | -13.1 Milliliter (mL) | Standard Deviation 31.5 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Visit 13 (Month 40); n=1 | 35.0 Milliliter (mL) | — |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Study Conclusion/Withdrawal;n=29 | -1.7 Milliliter (mL) | Standard Deviation 31.01 |
| RTG IR | Change From Baseline in Post-void Residual (PVR) Bladder Ultrasound Volumes | Follow-Up Visit; n=3 | -22.0 Milliliter (mL) | Standard Deviation 53.7 |
Primary
Change From Baseline in Red Blood Cell (RBC) Count
Blood samples were collected from participants to evaluate change from Baseline in RBC count. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 1- Day 1; n=30 | -0.03 Tetra unit per liter (TI/L) | Standard Deviation 0.266 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 2 - Month 1; n=28 | -0.06 Tetra unit per liter (TI/L) | Standard Deviation 0.256 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 3 - Month 3; n=26 | -0.03 Tetra unit per liter (TI/L) | Standard Deviation 0.241 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 4 - Month 6; n=18 | 0.01 Tetra unit per liter (TI/L) | Standard Deviation 0.227 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 5 - Month 9; n=17 | 0.05 Tetra unit per liter (TI/L) | Standard Deviation 0.218 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 6 - Month 12; n=15 | 0.04 Tetra unit per liter (TI/L) | Standard Deviation 0.188 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 7 - (Month 16); n=14 | 0.04 Tetra unit per liter (TI/L) | Standard Deviation 0.198 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 8 - (Month 20); n=12 | 0.19 Tetra unit per liter (TI/L) | Standard Deviation 0.207 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 9 - (Month 24); n=11 | 0.22 Tetra unit per liter (TI/L) | Standard Deviation 0.214 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 10 -(Month 28); n=10 | 0.17 Tetra unit per liter (TI/L) | Standard Deviation 0.2 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 11- (Month 32); n=9 | 0.41 Tetra unit per liter (TI/L) | Standard Deviation 0.322 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Visit 12- (Month 36); n=4 | 0.45 Tetra unit per liter (TI/L) | Standard Deviation 0.265 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | StudyConclusion/Withdrawal; n=28 | 0.13 Tetra unit per liter (TI/L) | Standard Deviation 0.229 |
| RTG IR | Change From Baseline in Red Blood Cell (RBC) Count | Follow-Up Visit; n=5 | 0.16 Tetra unit per liter (TI/L) | Standard Deviation 0.241 |
Primary
Change From Baseline in Red Cell Distribution Width (RDW)
Blood samples were collected from participants to evaluate change from Baseline in RDW. RDW is a parameter that measures variation in red blood cell size or red blood cell volume. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 10 -(Month 28); n=10 | 0.35 Percentage of width | Standard Deviation 0.665 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 1- Day 1; n=30 | 0.31 Percentage of width | Standard Deviation 0.887 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 2 - Month 1; n=28 | 0.43 Percentage of width | Standard Deviation 0.716 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 3 - Month 3; n=26 | 0.18 Percentage of width | Standard Deviation 1.016 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 4 - Month 6; n=18 | -0.33 Percentage of width | Standard Deviation 0.806 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 5 - Month 9; n=17 | -0.03 Percentage of width | Standard Deviation 1.025 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 6 - Month 12; n=15 | 0.01 Percentage of width | Standard Deviation 0.684 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 7 - (Month 16); n=14 | 0.13 Percentage of width | Standard Deviation 0.685 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 8 - (Month 20); n=12 | -0.33 Percentage of width | Standard Deviation 0.735 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 9 - (Month 24); n=11 | -0.01 Percentage of width | Standard Deviation 0.468 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 11- (Month 32); n=9 | -0.36 Percentage of width | Standard Deviation 0.814 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Visit 12- (Month 36); n=4 | -0.33 Percentage of width | Standard Deviation 0.69 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Study Conclusion/Withdrawal; n=28 | -0.01 Percentage of width | Standard Deviation 1.009 |
| RTG IR | Change From Baseline in Red Cell Distribution Width (RDW) | Follow-Up Visit; n=5 | -0.14 Percentage of width | Standard Deviation 0.885 |
Primary
Change From Baseline in Urine Albumin/Creatinine Ratio
Urine samples were collected from participants to evaluate change from Baseline in urine albumin/creatinine ratio. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated. NA indicates data was not available as standard deviation could not be calculated for single participant.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 1-Day 1; n=22 | -0.05 Ratio | Standard Deviation 1.603 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 2 - Month 1; n=19 | 0.16 Ratio | Standard Deviation 0.932 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 3 - Month 3; n=18 | 1.51 Ratio | Standard Deviation 5.755 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 4 - Month 6; n=14 | -0.32 Ratio | Standard Deviation 1.342 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 5 - Month 9; n=12 | -0.26 Ratio | Standard Deviation 1.006 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 6 - Month 12; n=10 | 9.80 Ratio | Standard Deviation 31.071 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 7-(Month 16); n=8 | 0.69 Ratio | Standard Deviation 1.733 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 8 - (Month 20); n=7 | -0.24 Ratio | Standard Deviation 0.547 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 9 - (Month 24); n=7 | -0.34 Ratio | Standard Deviation 2.07 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 10-(Month 28); n=6 | 0.38 Ratio | Standard Deviation 1.45 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 11-(Month 32); n=6 | 0.87 Ratio | Standard Deviation 1.519 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Visit 12-(Month 36); n=1 | 0.80 Ratio | — |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Study Conclusion/Withdrawal;n=17 | 0.51 Ratio | Standard Deviation 1.715 |
| RTG IR | Change From Baseline in Urine Albumin/Creatinine Ratio | Follow-Up Visit; n=5 | 3.30 Ratio | Standard Deviation 7.044 |
Primary
Change From Baseline in Urine Creatinine Concentration
Urine samples were collected from participants to evaluate change from Baseline in Urine creatinine concentration. Baseline was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Mean and SD were calculated.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 1-Day 1; n=30 | -1803.3 µmol/L | Standard Deviation 6012.94 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 2 - Month 1; n=27 | -1725.9 µmol/L | Standard Deviation 6632.88 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 3 - Month 3; n=25 | -508.0 µmol/L | Standard Deviation 6155.28 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 4 - Month 6; n=19 | -94.7 µmol/L | Standard Deviation 7902.92 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 5 - Month 9; n=17 | -58.8 µmol/L | Standard Deviation 6676.18 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 6 - Month 12; n=15 | -286.7 µmol/L | Standard Deviation 3000.21 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 7-(Month 16); n=14 | -235.7 µmol/L | Standard Deviation 3996.27 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 8 - (Month 20); n=12 | -341.7 µmol/L | Standard Deviation 7648.46 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 9 - (Month 24); n=11 | -81.8 µmol/L | Standard Deviation 5230.07 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 10-(Month 28); n=10 | 4940.0 µmol/L | Standard Deviation 9857.11 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 11-(Month 32); n=9 | 2944.4 µmol/L | Standard Deviation 6495.98 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Visit 12-(Month 36); n=3 | 1000.0 µmol/L | Standard Deviation 11887.39 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Study Conclusion/Withdrawal;n=27 | -1781.5 µmol/L | Standard Deviation 5805.11 |
| RTG IR | Change From Baseline in Urine Creatinine Concentration | Follow-Up Visit; n=5 | 7100.0 µmol/L | Standard Deviation 4959.33 |
Primary
Number of Participants Who Discontinued From RTG
The number of participants who discontinued from RTG treatment has been presented.
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants Who Discontinued From RTG | Day 498 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 0 | 0 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 3 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 17 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 62 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 66 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 98 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 111 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 126 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 163 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 168 | 2 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 169 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 229 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 240 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 287 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 339 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 413 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 559 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 650 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 781 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 852 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 927 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 930 | 0 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 943 | 0 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 1007 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 1008 | 1 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 1098 | 0 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 1169 | 0 Participants |
| RTG IR | Number of Participants Who Discontinued From RTG | Day 1233 | 0 Participants |
Primary
Number of Participants With Abnormal Urinalysis Values (Categorical Data)
Urine samples were collected from participants to analyze presence of abnormal urinalysis parameters including glucose, ketones, RBC, WBC, occult blood and protein. Abnormal urinalysis values have been presented for all parameters. Only those participants with data available at specific time points were analyzed (represented by n= X in the category titles).
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Follow up, Protein, 1+, n= 5 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day1, Glucose, 4+or 2 or more g/dL,n=30 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 1-3,n=29 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 3-5, n=29 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 5-10, n=29 | 6 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 10-15, n=29 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 15-25, n=29 | 6 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 25-50, n=29 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, RBC, 50-100, n=29 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, WBC,1-3, n=29 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, WBC,3-5, n=29 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, WBC,5-10, n=29 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, Occult Blood,1+, n=30 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, Occult Blood,4+, n=30 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 1 Day 1, protein, 1+, n=30 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, Glucose,1+ or 1/4 g/dL, n=28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, Glucose,4+or 2 or more g/dL,n=28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, Ketone 1+, n=28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, RBC, 1-3, n=27 | 7 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, RBC, 3-5, n=27 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, RBC, 5-10, n=27 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, RBC, 10-15, n=27 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, RBC, 15-25, n=27 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, RBC, 50-100, n=27 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1,WBC,1-3, n=27 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, WBC,3-5, n=27 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, Occult Blood,1+, n=28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 2 Month 1, protein, 1+, n=28 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, Ketones,1+, n=26 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC, 1-3, n=26 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC, 3-5, n=26 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC, 5-10, n=26 | 6 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC, 10-15, n=26 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC, 15-25, n=26 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC, 25-50, n=26 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, RBC,innumerable, n=26 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, WBC,1-3, n=26 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, WBC,15-25, n=26 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, WBC,innumerable, n=26 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, Occult Blood,1+, n=26 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, Occult Blood,4+, n=26 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 3 Month 3, protein, 1+, n=26 | 6 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, Glucose,3+ or 1 g/dL, n=19 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, RBC, 1-3, n=19 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, RBC, 3-5, n=19 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, RBC, 5-10, n=19 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6 RBC, 10-15,n=19 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, RBC, 15-25, n=19 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, RBC, 25-50, n=19 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, RBC, 50-100, n=19 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, WBC,1-3, n=19 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, WBC,3-5, n=19 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, Occult Blood,1+, n=19 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 4 Month 6, protein, 1+,n=19 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, Glucose,2+ or 1/2 g/dL, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, Glucose,3+ or 1 g/dL, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, 1-3, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, 3-5, n=17 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, 5-10, n=17 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, 10-15, n=17 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, 15-25, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, 25-50, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, RBC, innumerable, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, WBC,1-3, n=17 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, WBC,15-25, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, WBC, innumerable, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9,Occult Blood,1+, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, Occult Blood,4+, n=17 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 5 Month 9, protein, 1+, n=17 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6 Month 12, RBC, 1-3, n= 15 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6 Month 12, RBC, 3-5, n= 15 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6 Month 12, RBC, 5-10, n= 15 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6 Month 12, RBC, 10-15, n= 15 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6 Month 12, RBC, 15-25, n= 15 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6, Month 12, WBC, 1-3, n= 15 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6, Month 12, WBC, 3-5, n= 15 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6, Month 12, Occult blood, 1+, n= 15 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6, Month 12, Protein, 1+, n= 15 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 6, Month 12, Protein, 2+, n= 15 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7,Month16,Glucose, 4+ or 2 or more g/dL,n=14 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, Ketone, 1+, n= 14 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, RBC, 1-3, n= 13 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, RBC, 3-5, n= 13 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, RBC, 5-10, n= 13 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, RBC, 10-15, n= 13 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, RBC, 25-50, n= 13 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, WBC, 1-3, n= 13 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, WBC, 3-5, n= 13 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, Occult blood, 1+, n= 14 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, Occult blood, 4+, n= 14 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 7, Month 16, Protein, 1+, n= 14 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, RBC, 1-3, n= 12 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, RBC, 3-5, n= 12 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, RBC, 10-15, n= 12 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, RBC, 15-25, n= 12 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, RBC, 25-50, n= 12 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, WBC, 1-3, n= 12 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, WBC, 3-5, n= 12 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 8, Month 20, Occult blood, 1+, n= 12 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9,Month24,Glucose,4+ or 2 or more g/dL,n=11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, RBC, 1-3, n= 11 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, RBC, 3-5, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, RBC, 5-10, n= 11 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, RBC, 10-15, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, RBC, 50-100, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, WBC, 3-5, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, WBC, Innumerable, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, Occult blood, 1+, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, Occult blood, 4+, n= 11 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, Protein, 1+, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 9, Month 24, Protein, 2+, n= 11 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10,Month28,Glucose,4+ or 2 or more g/dL,n=10 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, RBC, 1-3, n= 9 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, RBC, 3-5, n= 9 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, RBC, 5-10, n= 9 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, RBC, 25-50, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, WBC, 1-3, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, Occult blood, 1+, n= 10 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 10, Month 28, Protein, 1+, n= 10 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11,Month 32,Glucose,4+ or 2 or more g/dL,n=9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, RBC, 3-5, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, RBC, 5-10, n= 9 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, RBC, 10-15, n= 9 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, RBC, 25-50, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, RBC, 50-100, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, WBC, 1-3, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, WBC, 10-15, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, WBC, innumerable, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, Occult blood, 1+, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, Occult blood, 2+, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 11, Month 32, Occult blood, 4+, n= 9 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 12,Month 36,Glucose,4+ or 2 or more g/dL,n=4 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 12, Month 36, RBC, 3-5, n= 4 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 12, Month 36, RBC, 5-10, n= 4 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Visit 12, Month 36, Occult blood, 1+, n= 4 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal,Glucose,3+or1g/dL,n=28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal,Glucose,4+or2g/dL,n=28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, Ketones, trace, n= 28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, RBC, 1-3, n= 28 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, RBC, 3-5, n= 28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, RBC, 5-10, n= 28 | 7 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, RBC, 10-15, n= 28 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, RBC, 15-25, n= 28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, RBC, 25-50, n= 28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, WBC, 1-3, n= 28 | 4 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, WBC, 3-5, n= 28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, WBC, 5-10, n= 28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, WBC 10-15, n= 28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, WBC 15-25, n= 28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, Occult blood,1+ n= 28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, Occult blood,2+ n= 28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, Occult blood,4+ n= 28 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, Protein, trace, n= 28 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Study conclusion/Withdrawal, Protein, 1+, n= 28 | 5 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Follow up, Ketones, trace, n= 5 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Follow up, RBC, 1-3, n= 5 | 1 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Follow up, RBC, 5-10, n= 5 | 2 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Follow up, WBC, 1-3, n= 5 | 3 Participants |
| RTG IR | Number of Participants With Abnormal Urinalysis Values (Categorical Data) | Follow up, WBC, 10-15, n= 5 | 1 Participants |
Primary
Number of Participants With PCC Values of Change From Baseline for Body Weight
Body weight of participants were measured as a measure of safety. PCC range for body weight was increase or decrease of \>=7 percent. A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with PCC values of body weight at any Post-Baseline visit were presented.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Body Weight | Body weight;increase by >=7 percent | 11 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Body Weight | Body weight; decrease by >=7 percent | 4 Participants |
Primary
Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters
Single measurements of 12-lead ECGs were obtained in a supine position after at least 10 minutes of rest using an ECG machine that automatically calculates the heart rate (HR) as beats per minute (bpm) and measures PR, QRS, Bazett's correction QT interval (QTcB) and Friedericia's correction QT interval (QTcF) in milliseconds (msec). A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with PCC values of ECG parameters at any Post-Baseline visit were presented. For the 'Any Post Baseline' value, only the worst case finding was counted for each participant.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | HR <50 bpm, decreased from Baseline>=15 bpm | 1 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | HR >100 bpm, increased from Baseline >=15 bpm | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | PR interval >=210 msec, increased from Baseline | 1 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QRS interval >=120 msec, increased from Baseline | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Post-Baseline QTc>=450, Baseline<450 msec | 5 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Post-Baseline QTc>=480, Baseline < 480 msec | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Post-Baseline QTc>500 msec | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Post-Baseline QTc>=500, Baseline <500msec | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Increase in QTc of >30 msec from Baseline | 3 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Increase in QTc of >30,<=60 msecfrom Baseline | 3 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcB:Increase in QTc of >60 msec from Baseline | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF:Post-Baseline QTc>=450, Baseline<450 msec | 1 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF:Post-Baseline QTc>=480, Baseline<480 msec | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF: Post-Baseline QTc>500 msec | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF:Post-Baseline QTc>=500, Baseline<500 msec | 0 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF:Increase in QTc of >30 msec from Baseline | 3 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF:Increase in QTcof >30,<=60 msec from Baseline | 3 Participants |
| RTG IR | Number of Participants With PCC Values of Change From Baseline for Electrocardiogram (ECG) Parameters | QTcF:Increase in QTc of >60 msec from Baseline | 0 Participants |
Primary
Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs
The vital signs were evaluated as per PCC Criteria. The vital signs included systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR). The vital signs were measured in a seated position after 5 minutes of rest. PCC range for DBP was increase or decrease of \>=20, for SBP was increase or decrease of \>=15 and for heart rate was increase or decrease of \>=15. A Baseline assessment in this OLE study was defined as the last assessment of that endpoint in parent study RTG114855 taken prior to the first active treatment with RTG IR. Change from Baseline was defined as post-Baseline value minus Baseline value. Number of participants with vital sign values of PCC at any Post-Baseline visit were presented.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | DBP; increase by >=20 | 4 Participants |
| RTG IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | DBP; decrease by >=20 | 9 Participants |
| RTG IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | SBP; increase by >=15 | 5 Participants |
| RTG IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | SBP; decrease by >=15 | 5 Participants |
| RTG IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | HR; increase by >=15 | 9 Participants |
| RTG IR | Number of Participants With Potential Clinical Concern (PCC) Values of Change From Baseline for Vital Signs | HR; decrease by >=15 | 5 Participants |
Primary
Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of RTG
The ophthalmologist/retina specialist determined the presence or absence of retinal and non-retinal ocular abnormalities. Retinal abnormalities included abnormalities in the macula and/or the peripheral retina. This analysis was performed on the All SFUCP Subjects population which comprised of all participants who enter the SFUCP.
Time frame: Up to 1.4 years
Population: All SFUCP Subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of RTG | Retinal pigmentary abnormality | 0 Participants |
| RTG IR | Number of Participants With Resolution of Abnormal Eye Pigmentation After Discontinuation of RTG | Non-retinal ocular pigmentary abnormality | 0 Participants |
Primary
Number of Participants With Resolution of Dermatologist-confirmed Abnormal Discoloration After Discontinuation of RTG
The skin examination included assessment of the skin around the eyes and the eye lids, lips, nails, and mucosa. Participants who enter the SFUCP who had on-treatment finding(s) of abnormal discoloration of skin, lips, nails or mucosa confirmed by a dermatologist, underwent assessments performed by a dermatologist at 6-monthly intervals.
Time frame: Up to 1.4 years
Population: All SFUCP Subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTG IR | Number of Participants With Resolution of Dermatologist-confirmed Abnormal Discoloration After Discontinuation of RTG | 0 Participants |
Primary
Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Number of participants with suicidal ideation or behavior during treatment were assessed using the C-SSRS score scale. It is a brief questionnaire designed to assess severity and change in suicidality by integrating both behavior and ideation using a semi-structured interview to probe participant responses. It consists of an assessment of suicidal ideation (ranging from desire to be dead to active suicidal ideation with specific plan and intent) and an assessment of suicidal behavior (ranging from preparatory acts or behavior to completed suicide).
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal ideation | 1 Participants |
| RTG IR | Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) | Suicidal behavior | 0 Participants |
Primary
Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function is SAE. TEAE refers to an AE for which the onset was on or after the date of the first RTG dose in this study and on or before 30 days after the last RTG dose date. AEs that started in the parent study that worsened in this study were also considered as TEAEs. Safety population comprised of participants who take at least 1 dose of study medication after they have enrolled into this OLE study. Number of participants with TE-SAEs and non-SAEs (with incidence \>= 5%) have been presented.
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTG IR | Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs | Any non-SAE | 23 Participants |
| RTG IR | Number of Participants With Treatment Emergent (TE) Serious Adverse Events (SAEs) and Non-SAEs | Any SAE | 5 Participants |
Primary
Percentage of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination
Percentage of participants with a clinically significant decrease in visual acuity from initial examination were evaluated. Only abnormalities occurring on-treatment in study RTG114873 were presented.
Time frame: Up to 4 years
Population: Safety Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Participants With a Clinically Significant Decrease in Visual Acuity From Initial Examination | 16 Percentage of participants |
Primary
Percentage of Participants With Decrease in Confrontational Visual Field From Initial Examination
Percentage of participants with decrease in confrontational visual field from initial examination were evaluated. Only abnormalities occurring on-treatment in study RTG114873 were presented.
Time frame: Up to 4 years
Population: Safety Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Participants With Decrease in Confrontational Visual Field From Initial Examination | 21 Percentage of participants |
Primary
Percentage of Participants With Dermatologist-confirmed Abnormal Discoloration
Percentage of participants with abnormal findings after skin examination (including the skin around the eyes and the eyelids, lips, nails, or mucosa) were evaluated.
Time frame: Up to 4 years
Population: Safety Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Participants With Dermatologist-confirmed Abnormal Discoloration | 0 Percentage of participants |
Primary
Percentage of Participants With Pigmentation of Non-retinal Ocular Tissues
Percentage of participants with abnormal findings after eye examination were evaluated. Abnormalities detected on-treatment in study RTG114873 were presented. Pigmentation of non-retinal ocular tissues included pigmentation of the sclera and/or conjunctiva, cornea, iris and lens.
Time frame: Up to 4 years
Population: Safety Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Participants With Pigmentation of Non-retinal Ocular Tissues | 32 Percentage of participants |
Primary
Percentage of Participants With Retinal Pigmentary Abnormalities
Percentage of participants with abnormal findings after eye examination were evaluated. Abnormalities detected on-treatment in study RTG114873 were presented. Retinal pigmentary abnormalities included abnormalities in the macula, peripheral retina and unspecified location.
Time frame: Up to 4 years
Population: Safety Population. Only those participants with data available at specific time point were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Participants With Retinal Pigmentary Abnormalities | 18 Percentage of participants |
Primary
Percentage of Participants With TEAEs Leading to Study Discontinuation
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAE refers to an AE for which the onset was on or after the date of the first RTG dose in this study and on or before 30 days after the last RTG dose date. Percentage of participants with TEAEs leading to study discontinuation were presented.
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Participants With TEAEs Leading to Study Discontinuation | 17 Percentage of Participants |
Primary
Percentage of Responders to POS Frequency
A responder was defined as a participant experiencing a \>=50 percent reduction in 28 day total POS frequency from Baseline. A responder rate was calculated overall and based on duration of exposure. As this was an OLE study, Baseline was defined by the parent study Baseline period. Percentage of responders were evaluated from study RTG114873 Day 1 through the last dosing day, excluding the Taper Phase.
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RTG IR | Percentage of Responders to POS Frequency | 23 Percentage of responders |
Primary
Percent Change From Baseline in 28-day Total POS Frequency
The 28-day total POS frequency was calculated as the number of total POS reported during the treatment phase, divided by the number of applicable days in the treatment phase, then multiplying this ratio by 28. In this formula, innumerable seizures were counted as 10 seizures and status epilepticus was counted as 1 seizure. As this was an OLE study, Baseline was defined by the parent study Baseline period. The percent change from Baseline was calculated as the 28-day total POS on-treatment frequency (during dosing in this study, not including the taper phase) minus the Baseline 28-day total POS frequency, with this difference being divided by the Baseline 28-day partial seizure rate, and the resulting quantity multiplied by 100. It was calculated as overall and by duration of exposure. Mean and SD were presented.
Time frame: Baseline and up to 4 years
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RTG IR | Percent Change From Baseline in 28-day Total POS Frequency | -29.37 Percent change | Standard Deviation 58.363 |
Primary
Potential of Hydrogen (pH) of Urine at Indicated Time Points
Urine Samples were collected to analyze pH. pH is a measure of hydrogen ion concentration and used to determine the acidity or alkalinity of urine. pH scale ranges from 0 to 14. A neutral pH is 7.0. The higher number indicates the more basic (alkaline) nature of urine and lower the number indicates the more acidic urine. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 1-Day 1; n=30 | 6.68 Scores on a scale | Standard Deviation 0.771 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 2 - Month 1; n=28 | 6.48 Scores on a scale | Standard Deviation 0.659 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 3 - Month 3; n=26 | 6.35 Scores on a scale | Standard Deviation 0.784 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 4 - Month 6; n=19 | 6.39 Scores on a scale | Standard Deviation 0.756 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 5 - Month 9; n=17 | 6.74 Scores on a scale | Standard Deviation 0.64 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 6 - Month 12; n=15 | 6.40 Scores on a scale | Standard Deviation 0.828 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 7-(Month 16); n=14 | 6.54 Scores on a scale | Standard Deviation 0.746 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 8 - (Month 20); n=12 | 6.71 Scores on a scale | Standard Deviation 0.62 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 9 - (Month 24); n=11 | 6.86 Scores on a scale | Standard Deviation 1.051 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 10-(Month 28); n=10 | 6.80 Scores on a scale | Standard Deviation 0.919 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 11-(Month 32); n=9 | 6.78 Scores on a scale | Standard Deviation 0.667 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Visit 12-(Month 36); n=4 | 6.88 Scores on a scale | Standard Deviation 0.25 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Study Conclusion/Withdrawal;n=28 | 6.52 Scores on a scale | Standard Deviation 0.687 |
| RTG IR | Potential of Hydrogen (pH) of Urine at Indicated Time Points | Follow-Up Visit; n=5 | 6.10 Scores on a scale | Standard Deviation 0.548 |
Primary
Specific Gravity of Urine at Indicated Time Points
Urine samples were collected to analyze specific gravity of urine. Specific gravity, is a measure of urine concentration and is measured using a chemical test. Specific gravity measurements provide a comparison of the amount of substances dissolved in urine as compared to pure water. If there were no solutes present, the specific gravity of urine would be 1.000 the same as pure water. Specific gravity between 1.002 and 1.035 could be considered as normal. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time frame: Up to 4 years
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 1-Day 1; n=30 | 1.0160 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00423 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 2 - Month 1; n=28 | 1.0157 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00522 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 3 - Month 3; n=26 | 1.0187 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00437 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 4 - Month 6; n=19 | 1.0161 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00542 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 5 - Month 9; n=17 | 1.0153 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00413 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 6 - Month 12; n=15 | 1.0157 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00458 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 7-(Month 16); n=14 | 1.0146 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00414 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 8 - (Month 20); n=12 | 1.0158 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00359 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 9 - (Month 24); n=11 | 1.0145 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.0035 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 10-(Month 28); n=10 | 1.0140 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00459 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 11-(Month 32); n=9 | 1.0139 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00486 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Visit 12-(Month 36); n=4 | 1.0150 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00408 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Study Conclusion/Withdrawal;n=28 | 1.0166 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00409 |
| RTG IR | Specific Gravity of Urine at Indicated Time Points | Follow-Up Visit; n=5 | 1.0198 Kilograms per meter^3 (Kg/m^3) | Standard Deviation 0.00476 |