Trial Outcomes & Findings for A Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Chronic Kidney Disease (CKD) Progression in Participants With CKD and Hyperkalaemia or at Risk of Hyperkalaemia (NCT NCT05056727)
NCT ID: NCT05056727
Last Updated: 2026-01-08
Results Overview
Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69)
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1112 participants
Primary outcome timeframe
Baseline (Maintenance phase) to visit 17 (week 69)
Results posted on
2026-01-08
Participant Flow
The study was conducted from 30 September 2021 to 07 February 2024 at 286 sites in 20 countries worldwide.
1112 participants entered the initiation phase of the study. 1049 of those participants entered the run-in phase of the study, and a total of 716 participants were randomized to treatment or placebo in the maintenance phase.
Participant milestones
| Measure |
Initiation Phase
Initiation phase only:
5 g SZC QD or 10 g SZC TID
|
Run-in Phase
Run-in phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: SZC
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|---|---|
|
Initiation Phase
STARTED
|
1112
|
0
|
0
|
0
|
|
Initiation Phase
COMPLETED
|
1078
|
0
|
0
|
0
|
|
Initiation Phase
NOT COMPLETED
|
34
|
0
|
0
|
0
|
|
Run-in Phase
STARTED
|
0
|
1049
|
0
|
0
|
|
Run-in Phase
COMPLETED
|
0
|
763
|
0
|
0
|
|
Run-in Phase
NOT COMPLETED
|
0
|
286
|
0
|
0
|
|
Maintenance Phase
STARTED
|
0
|
0
|
361
|
355
|
|
Maintenance Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Maintenance Phase
NOT COMPLETED
|
0
|
0
|
361
|
355
|
Reasons for withdrawal
| Measure |
Initiation Phase
Initiation phase only:
5 g SZC QD or 10 g SZC TID
|
Run-in Phase
Run-in phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: SZC
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|---|---|
|
Initiation Phase
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Initiation Phase
Study-specific; Study terminated; Other
|
20
|
0
|
0
|
0
|
|
Initiation Phase
Withdrawal by Subject
|
9
|
0
|
0
|
0
|
|
Initiation Phase
Physician Decision
|
4
|
0
|
0
|
0
|
|
Run-in Phase
Study-specific; Site terminated; Screen failure; Study terminated; Other
|
0
|
237
|
0
|
0
|
|
Run-in Phase
Death
|
0
|
3
|
0
|
0
|
|
Run-in Phase
Withdrawal by Subject
|
0
|
25
|
0
|
0
|
|
Run-in Phase
Physician Decision
|
0
|
20
|
0
|
0
|
|
Run-in Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Maintenance Phase
Site terminated; Study terminated; Other
|
0
|
0
|
332
|
314
|
|
Maintenance Phase
Withdrawal by Subject
|
0
|
0
|
19
|
21
|
|
Maintenance Phase
Physician Decision
|
0
|
0
|
4
|
16
|
|
Maintenance Phase
Lost to Follow-up
|
0
|
0
|
2
|
2
|
|
Maintenance Phase
Death
|
0
|
0
|
4
|
2
|
Baseline Characteristics
Full analysis set, participants with a non-missing value.
Baseline characteristics by cohort
| Measure |
Maintenance Phase: SZC
n=361 Participants
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=355 Participants
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
Total
n=716 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 Years
STANDARD_DEVIATION 12.3 • n=361 Participants
|
63.6 Years
STANDARD_DEVIATION 11.9 • n=355 Participants
|
64.0 Years
STANDARD_DEVIATION 12.1 • n=716 Participants
|
|
Age, Customized
18 yr ≤ Age < 65 yr
|
163 Participants
n=361 Participants
|
168 Participants
n=355 Participants
|
331 Participants
n=716 Participants
|
|
Age, Customized
Age ≥ 65 yr
|
198 Participants
n=361 Participants
|
187 Participants
n=355 Participants
|
385 Participants
n=716 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=361 Participants
|
132 Participants
n=355 Participants
|
254 Participants
n=716 Participants
|
|
Sex: Female, Male
Male
|
239 Participants
n=361 Participants
|
223 Participants
n=355 Participants
|
462 Participants
n=716 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
65 Participants
n=361 Participants
|
79 Participants
n=355 Participants
|
144 Participants
n=716 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
296 Participants
n=361 Participants
|
276 Participants
n=355 Participants
|
572 Participants
n=716 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=361 Participants
|
0 Participants
n=355 Participants
|
0 Participants
n=716 Participants
|
|
Race/Ethnicity, Customized
Asian
|
140 Participants
n=361 Participants
|
133 Participants
n=355 Participants
|
273 Participants
n=716 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
12 Participants
n=361 Participants
|
13 Participants
n=355 Participants
|
25 Participants
n=716 Participants
|
|
Race/Ethnicity, Customized
White
|
193 Participants
n=361 Participants
|
192 Participants
n=355 Participants
|
385 Participants
n=716 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=361 Participants
|
14 Participants
n=355 Participants
|
26 Participants
n=716 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
4 Participants
n=361 Participants
|
3 Participants
n=355 Participants
|
7 Participants
n=716 Participants
|
|
UACR
|
1032.5 mg/g
n=354 Participants • Full analysis set, participants with a non-missing value.
|
1017.0 mg/g
n=347 Participants • Full analysis set, participants with a non-missing value.
|
1018.0 mg/g
n=701 Participants • Full analysis set, participants with a non-missing value.
|
|
eGFR
|
41.0 mL/min/(1.73 m2)
STANDARD_DEVIATION 12.9 • n=348 Participants • Full analysis set, participants with a non-missing value.
|
40.4 mL/min/(1.73 m2)
STANDARD_DEVIATION 12.4 • n=347 Participants • Full analysis set, participants with a non-missing value.
|
40.7 mL/min/(1.73 m2)
STANDARD_DEVIATION 12.6 • n=695 Participants • Full analysis set, participants with a non-missing value.
|
|
S-K
|
4.41 mmol/L
STANDARD_DEVIATION 0.43 • n=348 Participants • Full analysis set, participants with a non-missing value.
|
4.45 mmol/L
STANDARD_DEVIATION 0.48 • n=348 Participants • Full analysis set, participants with a non-missing value.
|
4.43 mmol/L
STANDARD_DEVIATION 0.46 • n=696 Participants • Full analysis set, participants with a non-missing value.
|
PRIMARY outcome
Timeframe: Baseline (Maintenance phase) to visit 17 (week 69)Population: Full analysis set.
Total eGFR slope, Baseline (Maintenance phase) to visit 17 (week 69)
Outcome measures
| Measure |
Maintenance Phase: SZC
n=352 Participants
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=346 Participants
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|
|
Total eGFR Slope (Coprimary Analysis #1)
|
-5.2975 mL/min/(1.73 m2)/yr
Interval -6.6854 to -3.9097
|
-4.5622 mL/min/(1.73 m2)/yr
Interval -5.9969 to -3.1275
|
PRIMARY outcome
Timeframe: 12 weeks to visit 17 (week 69)Population: Full analysis set.
Chronic eGFR slope, 12 weeks to visit 17 (week 69)
Outcome measures
| Measure |
Maintenance Phase: SZC
n=352 Participants
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=346 Participants
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|
|
Chronic eGFR Slope (Coprimary Analysis #2)
|
-4.8705 mL/min/(1.73 m2)/yr
Interval -6.7222 to -3.0189
|
-2.8285 mL/min/(1.73 m2)/yr
Interval -4.7571 to -0.8999
|
SECONDARY outcome
Timeframe: From Baseline (Maintenance phase) up to week 97 (Maintenance phase)Population: Full analysis set.
Incidence of the composite of kidney failure outcomes comprising: sustained ≥ 40% decline in eGFR, onset of ESKD, and death from kidney failure is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.
Outcome measures
| Measure |
Maintenance Phase: SZC
n=359 Participants
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=354 Participants
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|
|
Incidence of the Composite of Kidney Failure Outcomes
|
7 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From Baseline (Maintenance phase) up to week 97 (Maintenance phase)Population: Full analysis set. Subjects on Valsartan/Lisinopril (RAASi) at randomisation.
Incidence of RAASi (lisinopril/valsartan) dose decrease is analyzed based on Cox regression model. Patients with no events are censored at end of maintenance phase or premature discontinuation.
Outcome measures
| Measure |
Maintenance Phase: SZC
n=359 Participants
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=354 Participants
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|
|
Incidence of RAASi Reduction
|
55 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: At visit 13 (week 24)Population: Full analysis set.
Urine albumin-to-creatinine ratio (UACR); mass concentration of albumin divided by mass concentration of creatinine, in urine; at visit 13 (week 24)
Outcome measures
| Measure |
Maintenance Phase: SZC
n=202 Participants
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=190 Participants
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|
|
UACR
|
1513.07 mg/g
Interval 1253.89 to 1772.24
|
1211.94 mg/g
Interval 943.14 to 1480.74
|
Adverse Events
Initiation Phase
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Run-in Phase
Serious events: 56 serious events
Other events: 221 other events
Deaths: 3 deaths
Maintenance Phase: SZC
Serious events: 66 serious events
Other events: 106 other events
Deaths: 4 deaths
Maintenance Phase: Placebo
Serious events: 42 serious events
Other events: 120 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Initiation Phase
n=1112 participants at risk
Initiation phase only:
5 g SZC QD or 10 g SZC TID
|
Run-in Phase
n=1049 participants at risk
Run-in phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: SZC
n=359 participants at risk
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=355 participants at risk
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|---|---|
|
General disorders
Sudden death
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/355 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Anal abscess
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Covid-19
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Covid-19 pneumonia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Campylobacter infection
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.85%
3/355 • Number of events 4 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/355 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Gangrene
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Influenza
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Localised infection
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/355 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.85%
3/355 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Pasteurella infection
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Periorbital cellulitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.38%
4/1049 • Number of events 4 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.1%
4/359 • Number of events 4 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Sepsis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Septic shock
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Extremity necrosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Hypertension
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.29%
3/1049 • Number of events 4 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.84%
3/359 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Hypotension
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
General disorders
Granuloma
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
General disorders
Oedema peripheral
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.4%
5/359 • Number of events 5 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Vertigo cns origin
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Product Issues
Device dislocation
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.7%
6/359 • Number of events 8 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.85%
3/355 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.84%
3/359 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Reproductive system and breast disorders
Breast mass
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Headache
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Nervous system disorders
Hypertensive cerebrovascular disease
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/355 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
General disorders
Fatigue
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Eye disorders
Cataract
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
General disorders
Accidental death
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
General disorders
Death
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Intervertebral disc injury
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Investigations
Blood glucose increased
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.84%
3/359 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.85%
3/355 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.19%
2/1049 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/359 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.56%
2/355 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/1049 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/359 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.10%
1/1049 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/359 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.00%
0/355 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
Other adverse events
| Measure |
Initiation Phase
n=1112 participants at risk
Initiation phase only:
5 g SZC QD or 10 g SZC TID
|
Run-in Phase
n=1049 participants at risk
Run-in phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: SZC
n=359 participants at risk
Maintenance phase only:
5 g SZC QOD to 15 g SZC QD, + Lisinopril/Valsartan
|
Maintenance Phase: Placebo
n=355 participants at risk
Maintenance phase only:
Placebo (for SZC), + Lisinopril/Valsartan
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.18%
2/1112 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.3%
14/1049 • Number of events 14 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.3%
12/359 • Number of events 12 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
2.0%
7/355 • Number of events 7 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
General disorders
Oedema peripheral
|
0.18%
2/1112 • Number of events 2 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.6%
38/1049 • Number of events 41 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
5.0%
18/359 • Number of events 21 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.7%
6/355 • Number of events 8 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Covid-19
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.4%
15/1049 • Number of events 15 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.3%
12/359 • Number of events 12 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
2.3%
8/355 • Number of events 8 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Infections and infestations
Nasopharyngitis
|
0.09%
1/1112 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.67%
7/1049 • Number of events 9 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.1%
11/359 • Number of events 14 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.7%
6/355 • Number of events 8 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.36%
4/1112 • Number of events 4 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.5%
16/1049 • Number of events 20 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
6.4%
23/359 • Number of events 30 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
26.2%
93/355 • Number of events 119 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
7.8%
82/1049 • Number of events 94 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
12.3%
44/359 • Number of events 58 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.28%
1/355 • Number of events 1 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Hypertension
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
4.6%
48/1049 • Number of events 52 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
5.0%
18/359 • Number of events 19 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.7%
13/355 • Number of events 15 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Vascular disorders
Hypotension
|
0.00%
0/1112 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
1.7%
18/1049 • Number of events 21 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.3%
12/359 • Number of events 12 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
2.0%
7/355 • Number of events 8 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
|
Gastrointestinal disorders
Constipation
|
0.27%
3/1112 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
2.9%
30/1049 • Number of events 30 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
3.1%
11/359 • Number of events 11 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
0.85%
3/355 • Number of events 3 • Visit 2 - Day 1 (Initiation Phase) up to Visit 20 - Week 97 (Maintenance Phase)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place