Trial Outcomes & Findings for Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event (NCT NCT02661217)
NCT ID: NCT02661217
Last Updated: 2021-04-26
Results Overview
Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1002 participants
Primary outcome timeframe
10 weeks after Randomization
Results posted on
2021-04-26
Participant Flow
Patients were randomized to pre-discharge group or post-discharged group.
The study consisted of 3 Epochs: the Screening Epoch (from signing of informed consent form to randomization), the treatment epoch (10 weeks following randomization), and a 16 weeks Follow-up Epoch following treatment epoch.
Participant milestones
| Measure |
LCZ696 Pre-discharge Treatment Initiation
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
Overall Study
STARTED
|
500
|
502
|
|
Overall Study
Started 10 Weeks Treatment Epoch
|
497
|
501
|
|
Overall Study
Completed 10 Weeks Treatment Epoch
|
460
|
455
|
|
Overall Study
COMPLETED
|
425
|
419
|
|
Overall Study
NOT COMPLETED
|
75
|
83
|
Reasons for withdrawal
| Measure |
LCZ696 Pre-discharge Treatment Initiation
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
Overall Study
Physician Decision
|
12
|
15
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Protocol Deviation
|
0
|
4
|
|
Overall Study
Non-compliance with study treatment
|
5
|
5
|
|
Overall Study
Death
|
21
|
15
|
|
Overall Study
Adverse Event
|
10
|
8
|
|
Overall Study
Withdrawal by Subject
|
15
|
19
|
|
Overall Study
Did not enter follow-up epoch
|
7
|
10
|
|
Overall Study
Death - no study drug received
|
1
|
2
|
|
Overall Study
Mis-randomized (not in treatment epoch)
|
3
|
1
|
Baseline Characteristics
Comparison of Pre- and Post-discharge Initiation of LCZ696 Therapy in HFrEF Patients After an Acute Decompensation Event
Baseline characteristics by cohort
| Measure |
LCZ696 Pre-discharge Treatment Initiation
n=500 Participants
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
n=502 Participants
Patients received first dose after discharge and up to 14 days thereafter.
|
Total
n=1002 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.7 years
STANDARD_DEVIATION 12.27 • n=5 Participants
|
67.0 years
STANDARD_DEVIATION 11.67 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 11.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
126 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
374 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
751 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
488 Participants
n=5 Participants
|
486 Participants
n=7 Participants
|
974 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeks after RandomizationPopulation: Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Percentage of patients achieving and maintaining LCZ696 200 mg bid for at least 2 weeks leading to Week 10
Outcome measures
| Measure |
LCZ696 Pre-discharge Treatment Initiation
n=493 Participants
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
n=489 Participants
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
Percentage of Patients Achieving the Target Dose of LCZ696 200 mg Bid at 10 Weeks Post Randomization
|
224 Participants
|
248 Participants
|
SECONDARY outcome
Timeframe: 10 weeks after RandomizationPopulation: Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Percentage of patients achieving and maintaining either LCZ696 100 mg and/or 200 mg bid for at least 2 weeks leading to Week 10
Outcome measures
| Measure |
LCZ696 Pre-discharge Treatment Initiation
n=493 Participants
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
n=489 Participants
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
Percentage of Patients Achieving and Maintaining Either LCZ696 100 mg and/or 200 mg Bid
|
306 Participants
|
335 Participants
|
SECONDARY outcome
Timeframe: 10 weeks after RandomizationPopulation: Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Percentage of patients achieving any dose of LCZ696 for at least 2 weeks leading to 10 weeks of treatment
Outcome measures
| Measure |
LCZ696 Pre-discharge Treatment Initiation
n=493 Participants
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
n=489 Participants
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
Percentage of Patients Achieving and Maintaining Any Dose of LCZ696
|
424 Participants
|
438 Participants
|
SECONDARY outcome
Timeframe: 10 weeks after Randomization AND 26 weeks after randomizationPopulation: Safety Population (SAF). The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Percentage of patients permanently discontinued from LCZ696 (1) up to week 10 due to AEs, and (2) up to week 26 due to any reasons
Outcome measures
| Measure |
LCZ696 Pre-discharge Treatment Initiation
n=493 Participants
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
n=489 Participants
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
Percentage of Patients Permanently Discontinued From Treatment
up to week 10 due to AEs
|
36 Participants
|
24 Participants
|
|
Percentage of Patients Permanently Discontinued From Treatment
up to week 26 due to any reasons
|
83 Participants
|
78 Participants
|
POST_HOC outcome
Timeframe: From randomization until 26 weeks after randomizationPopulation: Safety Population (SAF) and randomized patients who died prior to first dose of study drug. The SAF consisted of all randomized subjects who received at least one dose of study drug with the exception of those patients who were inadvertently randomized into the study. Subjects were analyzed according to treatment actually received.
Pre-treatment deaths were collected from randomization until first treatment with LCZ696. The period from randomization to first treatment was up to 14 days. On-treatment deaths were collected from first treatment with LCZ696 until 26 weeks post randomization.
Outcome measures
| Measure |
LCZ696 Pre-discharge Treatment Initiation
n=494 Participants
Patients received first dose at any point after Randomization but no later than 12 h before discharge.
|
LCZ696 Post-discharge Treatment Initiation
n=491 Participants
Patients received first dose after discharge and up to 14 days thereafter.
|
|---|---|---|
|
All Collected Deaths
Pre-treatment deaths
|
1 Participants
|
2 Participants
|
|
All Collected Deaths
On-treatment deaths
|
23 Participants
|
13 Participants
|
|
All Collected Deaths
All deaths
|
24 Participants
|
15 Participants
|
Adverse Events
Pre-discharge
Serious events: 159 serious events
Other events: 200 other events
Deaths: 23 deaths
Post-discharge
Serious events: 134 serious events
Other events: 201 other events
Deaths: 13 deaths
All Patients
Serious events: 293 serious events
Other events: 401 other events
Deaths: 36 deaths
Serious adverse events
| Measure |
Pre-discharge
n=493 participants at risk
Pre-discharge
|
Post-discharge
n=489 participants at risk
Post-discharge
|
All Patients
n=982 participants at risk
All patients
|
|---|---|---|---|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
3/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Gastritis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Lip swelling
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
3/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Angina pectoris
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Angina unstable
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Arrhythmia
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Atrial fibrillation
|
0.81%
4/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.0%
5/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.92%
9/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Atrial flutter
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Atrial tachycardia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Bradycardia
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiac arrest
|
0.81%
4/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiac failure
|
9.3%
46/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
9.2%
45/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
9.3%
91/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiac failure acute
|
2.2%
11/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.8%
9/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
2.0%
20/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.82%
4/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiogenic shock
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.0%
5/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
6/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Left ventricular failure
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Palpitations
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Sinus arrest
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Subileus
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Asthenia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Impaired healing
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Non-cardiac chest pain
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.0%
5/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.71%
7/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Oedema peripheral
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
3/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Pyrexia
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Sudden cardiac death
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
General disorders
Sudden death
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Hepatitis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.82%
4/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Catheter site abscess
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Cellulitis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Device related infection
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Diarrhoea infectious
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Erysipelas
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
3/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Gangrene
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Gastroenteritis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
3/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Influenza
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Localised infection
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Lung infection
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Pneumonia
|
1.4%
7/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.6%
8/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.5%
15/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Postoperative wound infection
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Q fever
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.82%
4/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Sepsis
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Septic phlebitis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Septic shock
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Urinary tract infection
|
0.81%
4/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
6/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Urosepsis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Blood creatinine increased
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Cardiac output decreased
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Ejection fraction abnormal
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
General physical condition abnormal
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Heart rate abnormal
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Hepatic enzyme abnormal
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
International normalised ratio increased
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Investigations
Weight increased
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Gout
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.2%
6/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.92%
9/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Aphasia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Brain injury
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Cognitive disorder
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Dizziness
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Headache
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Presyncope
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Sciatica
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Syncope
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
3/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.61%
6/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Product Issues
Device battery issue
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Product Issues
Device dislocation
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.4%
12/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.4%
7/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.9%
19/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.51%
5/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Renal failure
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.82%
4/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.71%
7/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.82%
4/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
4/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.82%
4/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.71%
7/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
6/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.0%
5/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.1%
11/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal haematoma
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.61%
3/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.4%
7/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
1.0%
10/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.31%
3/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
1/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Vascular disorders
Hypertension
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Vascular disorders
Hypotension
|
1.2%
6/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.41%
2/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.81%
8/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
1/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.10%
1/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.41%
2/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.00%
0/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
0.20%
2/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
Other adverse events
| Measure |
Pre-discharge
n=493 participants at risk
Pre-discharge
|
Post-discharge
n=489 participants at risk
Post-discharge
|
All Patients
n=982 participants at risk
All patients
|
|---|---|---|---|
|
General disorders
Oedema peripheral
|
4.1%
20/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
5.3%
26/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
4.7%
46/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
17/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
5.9%
29/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
4.7%
46/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
13.6%
67/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
12.1%
59/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
12.8%
126/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Nervous system disorders
Dizziness
|
6.5%
32/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
6.1%
30/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
6.3%
62/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Renal and urinary disorders
Renal impairment
|
7.3%
36/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
4.9%
24/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
6.1%
60/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Vascular disorders
Hypotension
|
14.4%
71/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
13.7%
67/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
14.1%
138/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
29/493 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
3.9%
19/489 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
4.9%
48/982 • From start of treatment until 26 weeks after randomization
Analysis is based on the Safety Population (SAF). It consists of all randomized patients who received at least one dose of study drug. Deaths not included in the SAF (i.e. did not receive study drug) are presented separately in the Participant Flow and . Patients are analyzed according to treatment actually received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER