Trial Outcomes & Findings for Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin (NCT NCT01225562)
NCT ID: NCT01225562
Last Updated: 2016-01-25
Results Overview
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
21379 participants
Primary outcome timeframe
Randomization up to 47 months
Results posted on
2016-01-25
Participant Flow
The Participant Flow shows patients randomized. This number is different from patients enrolled in the protocol section which includes patients who were enrolled, but not randomized.
Participant milestones
| Measure |
Ticagrelor 90 mg
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
Ticagrelor 60 mg twice daily (BD)
|
Placebo
Matching placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
7050
|
7045
|
7067
|
|
Overall Study
COMPLETED
|
6995
|
6989
|
7014
|
|
Overall Study
NOT COMPLETED
|
55
|
56
|
53
|
Reasons for withdrawal
| Measure |
Ticagrelor 90 mg
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
Ticagrelor 60 mg twice daily (BD)
|
Placebo
Matching placebo
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
52
|
50
|
52
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
1
|
Baseline Characteristics
Prevention of Cardiovascular Events (eg, Death From Heart or Vascular Disease, Heart Attack, or Stroke) in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin
Baseline characteristics by cohort
| Measure |
Ticagrelor 90 mg
n=7050 Participants
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
n=7045 Participants
Ticagrelor 60 mg twice daily (BD)
|
Placebo
n=7067 Participants
Matching placebo
|
Total
n=21162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 8.4 • n=93 Participants
|
65.2 years
STANDARD_DEVIATION 8.4 • n=4 Participants
|
65.4 years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
65.3 years
STANDARD_DEVIATION 8.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
1682 Participants
n=93 Participants
|
1661 Participants
n=4 Participants
|
1717 Participants
n=27 Participants
|
5060 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
5368 Participants
n=93 Participants
|
5384 Participants
n=4 Participants
|
5350 Participants
n=27 Participants
|
16102 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Randomization up to 47 monthsPopulation: Intention to treat (ITT) population defined as all participants who were randomized to study treatment
Participants with CV death, MI or Stroke. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death, MI or stroke within 3 years from randomization
Outcome measures
| Measure |
Ticagrelor 90 mg
n=7050 Participants
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
n=7045 Participants
Ticagrelor 60 mg twice daily (BD)
|
Placebo
n=7067 Participants
Matching placebo
|
|---|---|---|---|
|
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death), Myocardial Infarction (MI) or Stroke Within 3 Years From Randomization
|
7.8 Percentage of Patients
|
7.8 Percentage of Patients
|
9.0 Percentage of Patients
|
PRIMARY outcome
Timeframe: First dosing up to 48 monthsPopulation: The safety analysis set defined as all patients who took at least one dose of study drug
A Thrombolysis in Myocardial Infarction (TIMI) study group major bleeding is defined as any fatal bleeding (leading directly to death within 7 days), any intrcranial bleeding or any clinically overt signs of haemorrhage associated with a drop in Haemoglobin of \>= 5g/dL. Events were adjudicated by a clinical events committee. Censoring ocurrs at 7 days following last dose of study drug. The Kaplan-Meier estimate reports the percentage of patients who experienced a TIMI Major bleeding within 3 years from first dose of study drug
Outcome measures
| Measure |
Ticagrelor 90 mg
n=6988 Participants
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
n=6958 Participants
Ticagrelor 60 mg twice daily (BD)
|
Placebo
n=6996 Participants
Matching placebo
|
|---|---|---|---|
|
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced a TIMI Major Bleeding Within 3 Years From First Dose of Study Drug Units: Percentage of Patients
|
2.6 Percentage of Patients
|
2.3 Percentage of Patients
|
1.1 Percentage of Patients
|
SECONDARY outcome
Timeframe: Randomization up to 47 monthsPopulation: Intention to treat (ITT) population defined as all participants who were randomized to study treatment
Participants with CV death. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent, non-CV death or at the last time point of complete clinical event assessment. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who experienced CV Death within 3 years from randomization
Outcome measures
| Measure |
Ticagrelor 90 mg
n=7050 Participants
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
n=7045 Participants
Ticagrelor 60 mg twice daily (BD)
|
Placebo
n=7067 Participants
Matching placebo
|
|---|---|---|---|
|
Kaplan-Meier Estimate of the Percentage of Patients Who Experienced Cardiovascular Death (CV Death) Within 3 Years From Randomization
|
2.9 Percentage of Patients
|
2.9 Percentage of Patients
|
3.4 Percentage of Patients
|
SECONDARY outcome
Timeframe: Randomization up to 47 monthsPopulation: Intention to treat (ITT) population defined as all participants who were randomized to study treatment
Participants with death from any cause. If no event, censoring occurs at the earliest of the efficacy cut-off date 14 Sep 2014, withdrawal of consent or the last time point the particapant was known to be alive. Events were adjudicated by a blinded endpoint committee. The Kaplan-Meier estimate reports the percentage of patients who died from any cause within 3 years from randomization
Outcome measures
| Measure |
Ticagrelor 90 mg
n=7050 Participants
Ticagrelor 90 mg twice daily (BD)
|
Ticagrelor 60 mg
n=7045 Participants
Ticagrelor 60 mg twice daily (BD)
|
Placebo
n=7067 Participants
Matching placebo
|
|---|---|---|---|
|
Kaplan-Meier Estimate of the Percentage of Patients Who Died From Any Cause Within 3 Years From Randomization
|
5.1 Percentage of Patients
|
4.7 Percentage of Patients
|
5.2 Percentage of Patients
|
Adverse Events
Placebo
Serious events: 1757 serious events
Other events: 945 other events
Deaths: 0 deaths
Ticagrelor 60mg bd
Serious events: 1853 serious events
Other events: 1992 other events
Deaths: 0 deaths
Ticagrelor 90mg bd
Serious events: 1918 serious events
Other events: 2245 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6996 participants at risk
|
Ticagrelor 60mg bd
n=6958 participants at risk
|
Ticagrelor 90mg bd
n=6988 participants at risk
|
|---|---|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Drowning
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Gastrocardiac syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Fall
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.14%
10/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.13%
9/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Coagulation factor deficiency
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.34%
24/6988 • Number of events 25
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Splenic haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Spontaneous haematoma
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Spontaneous haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.07%
5/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
28/6996 • Number of events 28
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.29%
20/6958 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.27%
19/6988 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Angina pectoris
|
0.73%
51/6996 • Number of events 53
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.65%
45/6958 • Number of events 47
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.73%
51/6988 • Number of events 55
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Angina unstable
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Arrhythmia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrial fibrillation
|
0.96%
67/6996 • Number of events 73
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
1.4%
94/6958 • Number of events 104
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
1.1%
74/6988 • Number of events 88
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrial flutter
|
0.23%
16/6996 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.20%
14/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.19%
13/6988 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrial tachycardia
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrial thrombosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrioventricular block
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.19%
13/6996 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Bifascicular block
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Bradycardia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac arrest
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac asthma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac failure
|
0.83%
58/6996 • Number of events 73
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.76%
53/6958 • Number of events 70
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.77%
54/6988 • Number of events 69
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac failure acute
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.20%
14/6996 • Number of events 16
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.27%
19/6988 • Number of events 25
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.73%
51/6996 • Number of events 60
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.76%
53/6958 • Number of events 79
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
1.0%
70/6988 • Number of events 97
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac tamponade
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac valve disease
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiogenic shock
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiomyopathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Conduction disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Coronary artery disease
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Left ventricular failure
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Mitral valve calcification
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Myocardial infarction
|
0.16%
11/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Myocardial oedema
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Myocardial rupture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Myocarditis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Nodal rhythm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Palpitations
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Pericarditis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Right ventricular failure
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.10%
7/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Sinus bradycardia
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Sinus tachycardia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Subendocardial ischaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Tachycardia
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.13%
9/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.17%
12/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6958 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6988 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Auricular perichondritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Deafness
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Presbyacusis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Vertigo
|
0.10%
7/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Endocrine disorders
Goitre
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Endocrine disorders
Hyperthyroidism
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Age-related macular degeneration
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Cataract
|
0.20%
14/6996 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.23%
16/6958 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Diabetic retinopathy
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Diplopia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Endocrine ophthalmopathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Extraocular muscle paresis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Eyelid ptosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Glaucoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Opsoclonus myoclonus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Pterygium
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Retinal detachment
|
0.06%
4/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Retinal haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Strabismus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Tolosa-Hunt syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Eye disorders
Vitreous haemorrhage
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Anal polyp
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Anal stenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Appendiceal mucocoele
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Ascites
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Colitis
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Constipation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6988 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.06%
4/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diverticulum
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Enteritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Faecalith
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Food poisoning
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.19%
13/6988 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.20%
14/6958 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.26%
18/6988 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastritis
|
0.14%
10/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6988 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastritis hypertrophic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastroduodenitis haemorrhagic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal erosion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.11%
8/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.37%
26/6988 • Number of events 27
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal mucosal disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrointestinal vascular malformation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.14%
10/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Ileus
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.30%
21/6996 • Number of events 22
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.37%
26/6958 • Number of events 27
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.36%
25/6988 • Number of events 25
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Inguinal hernia strangulated
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Intussusception
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal achalasia
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatic duct obstruction
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Pancreatitis haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Papilla of Vater stenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Parotid gland inflammation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Proctitis haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Tongue blistering
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Gastrointestinal disorders
Vomiting
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Asthenia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Cardiac death
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Catheter site haemorrhage
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Chest discomfort
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Chest pain
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Death
|
0.60%
42/6996 • Number of events 42
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.49%
34/6958 • Number of events 34
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.60%
42/6988 • Number of events 42
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device battery issue
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device breakage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device defective
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device dislocation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device lead damage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device lead issue
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device malfunction
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device material issue
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Device occlusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Euthanasia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Fatigue
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Gait disturbance
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
General physical health deterioration
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Hernia obstructive
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Hypothermia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Impaired healing
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Implant site pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Injection site bruising
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Malaise
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Medical device complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Multi-organ failure
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Non-cardiac chest pain
|
1.6%
109/6996 • Number of events 118
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
1.6%
113/6958 • Number of events 124
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
1.6%
115/6988 • Number of events 122
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Pain
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Pyrexia
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Sudden cardiac death
|
0.47%
33/6996 • Number of events 33
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.39%
27/6958 • Number of events 27
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.39%
27/6988 • Number of events 27
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Sudden death
|
0.13%
9/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.11%
8/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Biliary fistula
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6958 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.16%
11/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.44%
31/6996 • Number of events 31
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.26%
18/6958 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.21%
15/6988 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cholestasis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Hyperplastic cholecystopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Anti-neutrophil cytoplasmic antibody positive vasculitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Drug hypersensitivity
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Hypersensitivity
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Reaction to food additive
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Immune system disorders
Sarcoidosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abdominal wall abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abdominal wall infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Abscess neck
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Acquired immunodeficiency syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Amoebiasis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Anal abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Appendicitis
|
0.13%
9/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Appendicitis perforated
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Arthritis infective
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Avian influenza
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bacterial prostatitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bartholin's abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Biliary sepsis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bronchitis
|
0.27%
19/6996 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.31%
22/6988 • Number of events 27
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bronchopneumonia
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cellulitis
|
0.20%
14/6996 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6958 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cellulitis laryngeal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cerebral toxoplasmosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Chest wall abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cholangitis suppurative
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cholecystitis infective
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Clostridium colitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Clostridium difficile infection
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Clostridium difficile sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Colonic abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Congo-Crimean haemorrhagic fever
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Cystitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Dengue fever
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Device related infection
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Diabetic foot infection
|
0.04%
3/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Diabetic gangrene
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Diverticulitis
|
0.17%
12/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Ear infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Encephalitis brain stem
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Endocarditis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Endocarditis bacterial
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Enterococcal sepsis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Enterocolitis infectious
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Epididymitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Epiglottitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Erysipelas
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Escherichia pyelonephritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Extradural abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Furuncle
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gangrene
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastroenteritis
|
0.26%
18/6996 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 16
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.26%
18/6988 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Gingivitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Groin infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
H1N1 influenza
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Helicobacter gastritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Hepatitis viral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Herpes simplex meningoencephalitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Herpes zoster
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Incision site infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infected dermal cyst
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infected fistula
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infectious colitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infectious pleural effusion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Influenza
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Labyrinthitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Laryngitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Leishmaniasis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Listeria sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Liver abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Lobar pneumonia
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Localised infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Lung infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Malaria
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Meningitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Muscle abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Myringitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Nasal abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Orchitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Osteomyelitis
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Otitis media chronic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pancreatic abscess
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Paraspinal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Parotitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Periodontitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Peritonitis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pilonidal cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia
|
1.1%
76/6996 • Number of events 83
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.99%
69/6958 • Number of events 72
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
1.1%
77/6988 • Number of events 86
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia bacterial
|
0.16%
11/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia cytomegaloviral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia necrotising
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pneumonia viral
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Post procedural infection
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Post procedural pneumonia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Postoperative wound infection
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Proctitis infectious
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pseudomonas infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pulmonary sepsis
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
2/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Pyopneumothorax
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Rectal abscess
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Respiratory tract infection
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Rhinitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Sepsis
|
0.21%
15/6996 • Number of events 16
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.29%
20/6958 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6988 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Septic necrosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Septic shock
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Sialoadenitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Sinusitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Soft tissue infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Streptococcal abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Subacute endocarditis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Subcutaneous abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Tonsillitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Toxoplasmosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Tracheitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Tuberculosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Urethritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Urinary bladder abscess
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Urinary tract infection
|
0.21%
15/6996 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.39%
27/6958 • Number of events 30
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.40%
28/6988 • Number of events 30
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Urosepsis
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.27%
19/6988 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Vestibular neuronitis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Viral diarrhoea
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Viral infection
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Wound infection
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Wound infection bacterial
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Yersinia infection
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Back injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Gas poisoning
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Gastrointestinal injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Haematuria traumatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Joint capsule rupture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Osteoradionecrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Pancreatic leak
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post gastric surgery syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.14%
10/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post procedural persistent drain fluid
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Postpericardiotomy syndrome
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Radial nerve injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Radiation dysphagia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Remnant gastritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Renal haematoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Spinal cord injury cervical
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Suture related complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.19%
13/6988 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Traumatic haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.16%
11/6996 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6958 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.26%
18/6988 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Traumatic spinal cord compression
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Urinary tract injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
VIIIth nerve injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Vascular injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Wound
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Blood electrolytes decreased
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Blood glucose decreased
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Blood pressure increased
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Blood urine present
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Clostridium test positive
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Ejection fraction decreased
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Lymph node palpable
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Occult blood positive
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Scan myocardial perfusion abnormal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Investigations
Weight increased
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.19%
13/6996 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.21%
15/6988 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.19%
13/6996 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6958 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.07%
5/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Obesity
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
9/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Facet joint syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
14/6996 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Joint ankylosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Meniscal degeneration
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle hypertrophy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.29%
20/6996 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.32%
22/6958 • Number of events 23
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.23%
16/6988 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Myalgia intercostal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.84%
59/6996 • Number of events 62
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.78%
54/6958 • Number of events 59
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.77%
54/6988 • Number of events 57
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Polymyositis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Resorption bone increased
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.17%
12/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.03%
2/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.03%
2/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Spondylolysis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Tendon calcification
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acinic cell carcinoma of salivary gland
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.04%
3/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ameloblastoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic large cell lymphoma T- and null-cell types
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Astrocytoma malignant
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Atypical fibroxanthoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
6/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of ureter
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign soft tissue neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.16%
11/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.03%
2/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone sarcoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer male
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer recurrent
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brenner tumour
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchioloalveolar carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix cancer metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage 0
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
2/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.20%
14/6958 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.20%
14/6988 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6988 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.03%
2/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage I
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epithelioid mesothelioma
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicle centre lymphoma, follicular grade I, II, III stage IV
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.11%
8/6996 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal tract adenoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrooesophageal cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.20%
14/6988 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage I
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6988 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma cutis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoplasmacytoid lymphoma/immunocytoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant anorectal neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant fibrous histiocytoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.14%
10/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of ampulla of Vater
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pancreas
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic bronchial carcinoma
|
0.04%
3/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic salivary gland cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal gammopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelofibrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm benign
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma recurrent
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage I
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma stage II
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma unspecified histology aggressive
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oncocytoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral cavity cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer recurrent
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage III
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancoast's tumour
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.09%
6/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paranasal sinus neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pelvic neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleomorphic adenoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.53%
37/6996 • Number of events 37
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.42%
29/6958 • Number of events 29
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.54%
38/6988 • Number of events 38
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage II
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma recurrent
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal oncocytoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer recurrent
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcomatoid mesothelioma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.03%
2/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Splenic marginal zone lymphoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of pharynx
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsillar neoplasm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.04%
3/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Undifferentiated nasopharyngeal carcinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urethral cancer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Urinary tract neoplasm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Brain injury
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Brain stem infarction
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Brain stem syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Carotid artery disease
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.21%
15/6988 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Central nervous system lesion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebellar ataxia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebral cyst
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebral infarction
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cervical cord compression
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cluster headache
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Cognitive disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Convulsion
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Dementia
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Demyelinating polyneuropathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Dizziness
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6988 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Epilepsy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Grand mal convulsion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Headache
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Hypercapnic coma
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
18/6996 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Loss of consciousness
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Migraine
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Mononeuritis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Monoparesis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Myoclonus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Nerve root compression
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Neuralgia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Neuritis cranial
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Parkinson's disease
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Parkinsonism
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Peripheral nerve paresis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Polyneuropathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Presyncope
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Quadriparesis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Radiculopathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Ruptured cerebral aneurysm
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Sciatica
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Senile dementia
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Serotonin syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Syncope
|
0.40%
28/6996 • Number of events 30
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.45%
31/6958 • Number of events 33
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.53%
37/6988 • Number of events 39
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Transient global amnesia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
VIth nerve paresis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Vagus nerve disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Vascular parkinsonism
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Alcoholism
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Anxiety
|
0.03%
2/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Completed suicide
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Confusional state
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Conversion disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Depressed mood
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Depression
|
0.11%
8/6996 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.16%
11/6988 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Major depression
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Panic attack
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Panic disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Psychiatric symptom
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Psychotic behaviour
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Somatoform disorder cardiovascular
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Bladder diverticulum
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Bladder neck sclerosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Bladder tamponade
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Calculus bladder
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Calculus urethral
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Calculus urinary
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Glomerulonephritis membranoproliferative
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Haematuria
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6988 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.11%
8/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.30%
21/6988 • Number of events 22
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal colic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal cyst
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal cyst ruptured
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal failure
|
0.21%
15/6996 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal failure acute
|
0.40%
28/6996 • Number of events 34
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.46%
32/6958 • Number of events 32
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.46%
32/6988 • Number of events 34
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.09%
6/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal impairment
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Renal tubular acidosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Ureteric rupture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urinary retention
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.06%
4/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.37%
26/6996 • Number of events 26
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.36%
25/6958 • Number of events 26
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.29%
20/6988 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Cervical cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Ovarian necrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Prostatic mass
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Prostatism
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Uterine cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Uterovaginal prolapse
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
7/6996 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
4/6996 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6988 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.64%
45/6996 • Number of events 65
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.56%
39/6958 • Number of events 62
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.77%
54/6988 • Number of events 74
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse panbronchiolitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.17%
12/6996 • Number of events 12
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.33%
23/6958 • Number of events 24
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.41%
29/6988 • Number of events 30
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epiglottic oedema
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.29%
20/6988 • Number of events 21
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Nocturnal dyspnoea
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural adhesion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
16/6996 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
6/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
17/6996 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6958 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.30%
21/6988 • Number of events 23
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.01%
1/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.10%
7/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.09%
6/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract inflammation
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6988 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Cutaneous sarcoidosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Dry gangrene
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Pyoderma gangrenosum
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.04%
3/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Accelerated hypertension
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Angiodysplasia
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic aneurysm
|
0.19%
13/6996 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.27%
19/6958 • Number of events 19
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.27%
19/6988 • Number of events 20
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic dissection rupture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic stenosis
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aortic thrombosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Aorto-duodenal fistula
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Arterial rupture
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Arteriovenous fistula
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Circulatory collapse
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Deep vein thrombosis
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Extremity necrosis
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Femoral artery occlusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hot flush
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hypertension
|
0.26%
18/6996 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.22%
15/6958 • Number of events 15
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6988 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hypertensive crisis
|
0.17%
12/6996 • Number of events 14
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.11%
8/6958 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 11
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hypertensive emergency
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hypotension
|
0.14%
10/6996 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.13%
9/6958 • Number of events 9
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6988 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hypothenar hammer syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Intermittent claudication
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Leriche syndrome
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Malignant hypertension
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
4/6996 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Penetrating atherosclerotic ulcer
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.21%
15/6996 • Number of events 18
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.14%
10/6958 • Number of events 10
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.24%
17/6988 • Number of events 17
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.04%
3/6996 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.24%
17/6996 • Number of events 22
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 7
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.07%
5/6996 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 4
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral circulatory failure
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral embolism
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral ischaemia
|
0.13%
9/6996 • Number of events 13
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.04%
3/6958 • Number of events 3
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6988 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.11%
8/6996 • Number of events 8
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.06%
4/6988 • Number of events 5
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Poor peripheral circulation
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Shock
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Shock haemorrhagic
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Steal syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Temporal arteritis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6958 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Thrombosis
|
0.03%
2/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Varicose vein
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.07%
5/6958 • Number of events 6
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.03%
2/6988 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/6996
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Vena cava thrombosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6988 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Venous insufficiency
|
0.01%
1/6996 • Number of events 2
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.01%
1/6958 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Vascular disorders
Venous thrombosis
|
0.01%
1/6996 • Number of events 1
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6958
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
0.00%
0/6988
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
Other adverse events
| Measure |
Placebo
n=6996 participants at risk
|
Ticagrelor 60mg bd
n=6958 participants at risk
|
Ticagrelor 90mg bd
n=6988 participants at risk
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Increased tendency to bruise
|
0.93%
65/6996 • Number of events 70
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
6.0%
419/6958 • Number of events 520
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
6.6%
464/6988 • Number of events 575
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
377/6996 • Number of events 469
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
5.2%
364/6958 • Number of events 486
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
5.3%
368/6988 • Number of events 490
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
111/6996 • Number of events 122
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
5.1%
353/6958 • Number of events 471
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
5.5%
385/6988 • Number of events 473
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
329/6996 • Number of events 362
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
12.6%
876/6958 • Number of events 1036
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
15.6%
1091/6988 • Number of events 1340
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.4%
165/6996 • Number of events 221
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
6.0%
420/6958 • Number of events 623
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
7.2%
505/6988 • Number of events 668
Adverse events are reported for the safety analysis set, that is patients who received at least one dose of study drug. Hence the number of participants at risk is different from the total number in Participant Flow, which includes all randomized patients.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place