Trial Outcomes & Findings for A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (NCT NCT03762850)
NCT ID: NCT03762850
Last Updated: 2025-06-10
Results Overview
24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
406 participants
Primary outcome timeframe
Baseline (Day 1) and at Week 36
Results posted on
2025-06-10
Participant Flow
The PROTECT study is a 114-week, randomized, multicenter, double-blind (DB), parallel-group, active control study, in participants with Immunoglobulin A nephropathy (IgAN) who had persistent overt proteinuria and remained at high risk of disease progression despite being on a stable dose (or doses) of an Angiotensin converting enzyme inhibitor (ACEI) and/or Angiotensin II receptor blocker (ARB) that was (were) a maximum tolerated dose
The study was conducted across 3 regions (North America, Europe, and Asia Pacific), 18 countries, and 156 sites. The results presented are based on the double-blind period of the study.
Participant milestones
| Measure |
Sparsentan
Participants randomized to Sparsentan received an initial dose of 200 milligrams (mg) (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of adverse events (AEs) or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
Participants randomized to Irbesartan received an initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Overall Study
STARTED
|
203
|
203
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
202
|
202
|
|
Overall Study
COMPLETED
|
199
|
191
|
|
Overall Study
NOT COMPLETED
|
4
|
12
|
Reasons for withdrawal
| Measure |
Sparsentan
Participants randomized to Sparsentan received an initial dose of 200 milligrams (mg) (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of adverse events (AEs) or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
Participants randomized to Irbesartan received an initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
9
|
Baseline Characteristics
A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy
Baseline characteristics by cohort
| Measure |
Sparsentan
n=202 Participants
Participants randomized to Sparsentan received an initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
n=202 Participants
Participants randomized to Irbesartan received an initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Total
n=404 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.6 Years
STANDARD_DEVIATION 12.76 • n=5 Participants
|
45.4 Years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
46.0 Years
STANDARD_DEVIATION 12.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
122 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
139 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
185 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
368 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
67 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
130 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
272 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and at Week 36Population: The Primary Analysis Set (PAS) is the subset of the Full Analysis Set at the time of the data extraction for primary analysis. Participants in the PAS were analyzed according to randomized treatment assignment.
24-hour urine sample was collected for analysis of UP/C via a mixed-model repeated-measures (MMRM) analysis. Missing responses were imputed prior to analysis using multiple imputation. Change from Baseline during the double-blind period in UP/C on the log scale was the dependent variable. Log Baseline UP/C was included as a covariate along with fixed effects for randomized treatment, time (ie, nominal visit in weeks), randomized treatment-by-time interaction, and randomization strata with participants as random effect. Estimates in log scale were back transformed. Baseline was defined as the last non-missing observation on or prior to the start of the dosing. Using Rubin's approach, estimated treatment effects are combined across all imputations to obtain overall estimates.
Outcome measures
| Measure |
Sparsentan
n=202 Participants
Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
n=202 Participants
Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Percent Change From Baseline in the Urine Protein/Creatinine (UP/C) at Week 36
|
-49.77 Percent change
Interval -54.98 to -43.95
|
-15.05 Percent change
Interval -23.72 to -5.39
|
SECONDARY outcome
Timeframe: From Day 1 to Week 110Population: Full Analysis Set.
The rate of change in eGFR from Day 1 to Week 110 (ie, over 110 weeks) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates.
Outcome measures
| Measure |
Sparsentan
n=202 Participants
Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
n=202 Participants
Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Total Slope of Estimated Glomerular Filtration Rate (eGFR) Over a 110-week Period
|
-2.9 milliliters/minute/1.73square meter/year
Interval -3.58 to -2.24
|
-3.9 milliliters/minute/1.73square meter/year
Interval -4.59 to -3.13
|
SECONDARY outcome
Timeframe: From Week 6 to Week 110 post randomizationPopulation: Full Analysis Set.
The rate of change in eGFR from Week 6 to Week 110 (ie, over 104 weeks following the initial acute effect of randomized therapy) was analyzed via a mixed-model random coefficients analysis. Missing responses were imputed prior to analysis using multiple imputation. Fixed effects for randomized treatment, Baseline eGFR, time (in weeks), randomized treatment-by-time interaction, and randomization strata were included. In addition, the model also included a random intercept and random slope for each participant. Using Rubin's approach, the estimated treatment effects are combined across all imputations to obtain the overall estimates.
Outcome measures
| Measure |
Sparsentan
n=202 Participants
Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
n=202 Participants
Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Annualized Slope of eGFR Following the Initial Acute Effect of Randomized Treatment (Chronic Slope)
|
-2.7 milliliters/minute/1.73square meter/year
Interval -3.43 to -2.05
|
-3.8 milliliters/minute/1.73square meter/year
Interval -4.6 to -3.07
|
Adverse Events
Sparsentan
Serious events: 75 serious events
Other events: 187 other events
Deaths: 0 deaths
Irbesartan
Serious events: 71 serious events
Other events: 177 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Sparsentan
n=202 participants at risk
Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
n=202 participants at risk
Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
20.8%
42/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
18.8%
38/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Appendicitis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Cellulitis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Cellulitis orbital
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Complicated appendicitis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Latent tuberculosis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Localised infection
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Ludwig angina
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Pneumonia
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Pyelonephritis acute
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Chronic kidney disease
|
3.0%
6/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
3.0%
6/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.0%
4/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
IgA nephropathy
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Proteinuria
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Perinephric collection
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Urinary retention
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Dizziness
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Hemiparesis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Migraine
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Syncope
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Constipation
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Cardiac arrest
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
General disorders
Malaise
|
0.99%
2/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
General disorders
Chest pain
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
General disorders
Hyperplasia
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
General disorders
Pyrexia
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Blood creatinine increased
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Skin and subcutaneous tissue disorders
Target skin lesion
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Vascular disorders
Hypotension
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Psychiatric disorders
Depression suicidal
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Eye disorders
Retinal detachment
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Eye disorders
Retinal tear
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
0.50%
1/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
Other adverse events
| Measure |
Sparsentan
n=202 participants at risk
Participants randomized to Sparsentan received initial dose of 200 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (400 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
Irbesartan
n=202 participants at risk
Participants randomized to Irbesartan received initial dose of 150 mg (ie, one-half the target dose) tablets over-encapsulated (blinded) with size 00 capsules for the first 2 weeks after randomization. At the Week 2 visit, titration was done up to the target dose (300 mg) based on blood pressure and lack of AEs or after the Week 2 laboratory results were available (ie, between the Week 2 and Week 4 visits).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
26.2%
53/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
22.8%
46/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
8.9%
18/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
8.9%
18/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
15/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
7.9%
16/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Infections and infestations
Urinary tract infection
|
3.5%
7/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.9%
12/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
15.8%
32/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
12.9%
26/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Gout
|
5.4%
11/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
3.5%
7/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.4%
11/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.9%
14/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
8.4%
17/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
12/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
7.9%
16/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
14/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
6.4%
13/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.0%
6/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.9%
12/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
2.0%
4/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
General disorders
Oedema peripheral
|
15.3%
31/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
11.9%
24/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
General disorders
Fatigue
|
8.4%
17/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.4%
11/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
9.4%
19/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
4.0%
8/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Gastrointestinal disorders
Nausea
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
2.5%
5/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.4%
15/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Blood creatinine increased
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
6.9%
14/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Lipase increased
|
5.9%
12/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
4.5%
9/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
10/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
4.0%
8/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Headache
|
13.4%
27/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
12.9%
26/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Nervous system disorders
Dizziness
|
14.9%
30/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
6.4%
13/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Proteinuria
|
6.4%
13/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
7.4%
15/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Renal impairment
|
3.5%
7/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
5.9%
12/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.9%
12/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
2.5%
5/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Vascular disorders
Hypertension
|
10.9%
22/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
13.9%
28/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Vascular disorders
Hypotension
|
12.9%
26/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
4.0%
8/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
15/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
3.5%
7/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
11/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
4.0%
8/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.9%
16/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
4.5%
9/202 • Up to Week 114
Safety Analysis Set comprised of all participants who were randomized and had received at least 1 dose of randomized therapy. The results presented are based on the double-blind period of the study.
|
Additional Information
Travere Therapeutics Call Center
Travere Therapeutics, Inc
Phone: 1-877-659-5518
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER