Trial Outcomes & Findings for Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) (NCT NCT02313909)
NCT ID: NCT02313909
Last Updated: 2019-01-09
Results Overview
Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
7213 participants
Primary outcome timeframe
From randomization until the efficacy cut-off date (median 326 days)
Results posted on
2019-01-09
Participant Flow
Study was conducted at multiple centers in 31 countries between 23 December 2014 (first participant first visit) and 15 February 2018 (last participant last visit).
Overall, 7582 participants were screened; of these 369 participants were screen failures. A total of 7213 participants were randomized, of which 92 never took study drug; 3562 were treated with rivaroxaban(Xarelto, BAY59-7939) /placebo and 3559 were treated with acetylsalicylic acid/placebo.
Participant milestones
| Measure |
Rivaroxaban 15 mg OD
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Overall Study
STARTED
|
3609
|
3604
|
|
Overall Study
Treated
|
3562
|
3559
|
|
Overall Study
COMPLETED
|
3552
|
3554
|
|
Overall Study
NOT COMPLETED
|
57
|
50
|
Reasons for withdrawal
| Measure |
Rivaroxaban 15 mg OD
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Overall Study
Consent withdrawn by participant
|
33
|
33
|
|
Overall Study
Lost to Follow-up
|
24
|
17
|
Baseline Characteristics
Intention-to-treat analysis set included all randomized participants.
Baseline characteristics by cohort
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
Total
n=7213 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
66.9 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
66.9 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1377 Participants
n=5 Participants
|
1400 Participants
n=7 Participants
|
2777 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2232 Participants
n=5 Participants
|
2204 Participants
n=7 Participants
|
4436 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
0 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
0 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Race (NIH/OMB)
Asian
|
716 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
698 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
1414 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
0 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
0 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
60 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
111 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Race (NIH/OMB)
White
|
2613 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
2605 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
5218 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
0 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
0 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
229 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
241 Participants
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
470 Participants
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
|
Stroke or TIA (prior to qualifying stroke) or Other medical history
Stroke or TIA
|
620 count of participants
n=5 Participants
|
643 count of participants
n=7 Participants
|
1263 count of participants
n=5 Participants
|
|
Stroke or TIA (prior to qualifying stroke) or Other medical history
Other medical history
|
2989 count of participants
n=5 Participants
|
2961 count of participants
n=7 Participants
|
5950 count of participants
n=5 Participants
|
|
Time from qualifying stroke to randomization
|
38.0 days
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
36.0 days
n=7 Participants • Intention-to-treat analysis set included all randomized participants.
|
37.0 days
n=5 Participants • Intention-to-treat analysis set included all randomized participants.
|
PRIMARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of the Composite Efficacy Outcome (Adjudicated)
|
5.14 event/100 participant-years
Interval 4.4 to 5.97
|
4.78 event/100 participant-years
Interval 4.07 to 5.58
|
PRIMARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (\>=) 2 grams per decilitre (g/dL) (20 grams per liter \[g/L\]; 1.24 millimoles per liter \[mmol/L\]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)
|
1.82 event/100 participant-years
Interval 1.39 to 2.33
|
0.67 event/100 participant-years
Interval 0.42 to 1.0
|
SECONDARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction
|
6.20 event/100 participant-years
Interval 5.38 to 7.1
|
5.85 event/100 participant-years
Interval 5.05 to 6.73
|
SECONDARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
All-cause mortality includes all deaths of participants due to any cause.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of All-Cause Mortality
|
1.88 event/100 participant-years
Interval 1.45 to 2.4
|
1.50 event/100 participant-years
Interval 1.12 to 1.97
|
SECONDARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (\>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to "moderate disability" (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from "moderately severe disability" (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
Stroke
|
5.11 event/100 participant-years
Interval 4.37 to 5.93
|
4.71 event/100 participant-years
Interval 4.01 to 5.51
|
|
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
Ischemic stroke
|
4.71 event/100 participant-years
Interval 4.01 to 5.51
|
4.56 event/100 participant-years
Interval 3.87 to 5.34
|
|
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
Disabling stroke
|
1.20 event/100 participant-years
Interval 0.86 to 1.62
|
0.84 event/100 participant-years
Interval 0.56 to 1.21
|
|
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
CV death(includes death due to hemorrhage)
|
0.99 event/100 participant-years
Interval 0.68 to 1.38
|
0.66 event/100 participant-years
Interval 0.42 to 1.0
|
|
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
Myocardial infarction
|
0.49 event/100 participant-years
Interval 0.29 to 0.79
|
0.67 event/100 participant-years
Interval 0.42 to 1.0
|
SECONDARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of Life-Threatening Bleeding Events
|
1.02 event/100 participant-years
Interval 0.71 to 1.42
|
0.43 event/100 participant-years
Interval 0.24 to 0.72
|
SECONDARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of Clinically Relevant Non-Major Bleeding Events
|
3.52 event/100 participant-years
Interval 2.91 to 4.21
|
2.32 event/100 participant-years
Interval 1.84 to 2.9
|
SECONDARY outcome
Timeframe: From randomization until the efficacy cut-off date (median 326 days)Population: Intention-to-treat analysis set included all randomized participants. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
Outcome measures
| Measure |
Rivaroxaban 15 mg OD
n=3609 Participants
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3604 Participants
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Incidence Rate of Intracranial Hemorrhage
|
0.70 event/100 participant-years
Interval 0.45 to 1.04
|
0.35 event/100 participant-years
Interval 0.18 to 0.61
|
Adverse Events
Rivaroxaban 15 mg OD
Serious events: 466 serious events
Other events: 308 other events
Deaths: 73 deaths
Acetylsalicylic Acid 100 mg OD
Serious events: 434 serious events
Other events: 294 other events
Deaths: 58 deaths
Serious adverse events
| Measure |
Rivaroxaban 15 mg OD
n=3562 participants at risk
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3559 participants at risk
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Pulmonary arteriovenous fistula
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemiparaesthesia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine with aura
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Multiple sclerosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Nervous system disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.25%
9/3562 • Number of events 10 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.25%
9/3559 • Number of events 9 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.28%
10/3562 • Number of events 10 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.22%
8/3559 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tension headache
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Transient global amnesia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Putamen haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Partial seizures
|
0.14%
5/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Central pain syndrome
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Post stroke seizure
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemianaesthesia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Pseudostroke
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Adjustment disorder with mixed anxiety and depressed mood
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcoholism
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Conversion disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Delirium
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression suicidal
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mania
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Obsessive-compulsive personality disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Panic disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Panic reaction
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Somnambulism
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Neurologic somatic symptom disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Alcohol use disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal haematoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal hypertension
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary retention
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Costovertebral angle tenderness
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.17%
6/3559 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Endometrial dysplasia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.22%
8/3559 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Atrial septal defect repair
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Finger amputation
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.17%
6/3559 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Lymphoedema
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Temporal arteritis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.14%
5/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.14%
5/3559 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
May-Thurner syndrome
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Product Issues
Device malfunction
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.22%
8/3562 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
36/3562 • Number of events 36 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
1.0%
37/3559 • Number of events 37 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.14%
5/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Endocarditis noninfective
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Goitre
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperparathyroidism
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Blindness
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.11%
4/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.22%
8/3559 • Number of events 10 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Diplopia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Macular oedema
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Ophthalmic vein thrombosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
7/3562 • Number of events 7 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.14%
5/3559 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatolithiasis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Hernia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.17%
6/3562 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic reaction
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Anaphylactic shock
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Corneal graft rejection
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis perforated
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Brain abscess
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Corneal abscess
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Diabetic gangrene
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Encephalitis viral
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Endophthalmitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Erysipelas
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.17%
6/3562 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Hepatitis A
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Kidney infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Localised infection
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Meningitis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Orchitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis externa
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Paronychia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritoneal abscess
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.39%
14/3562 • Number of events 14 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.39%
14/3559 • Number of events 14 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Renal abscess
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.17%
6/3562 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.17%
6/3559 • Number of events 7 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vestibular neuronitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urosepsis
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia necrotising
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.08%
3/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Neurocysticercosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bursitis infective
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Perichondritis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Acarodermatitis
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster oticus
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Biliary tract infection bacterial
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer haemorrhage
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.08%
3/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.17%
6/3562 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.14%
5/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.14%
5/3559 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Incorrect dosage administered
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Prostatic specific antigen increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Influenza A virus test positive
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.17%
6/3559 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Obesity
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Shock hypoglycaemic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic complication
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.31%
11/3562 • Number of events 12 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plica syndrome
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer stage IV
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic uterine cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage III
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal meningioma benign
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.14%
5/3559 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.22%
8/3559 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign bone neoplasm
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal squamous cell carcinoma
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Brain stem haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral venous thrombosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Chorea
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.20%
7/3562 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.22%
8/3559 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Rivaroxaban 15 mg OD
n=3562 participants at risk
Subjects received rivaroxaban 15 mg immediate-release film-coated tablet and matching placebo of acetylsalicylic acid orally once daily (OD).
|
Acetylsalicylic Acid 100 mg OD
n=3559 participants at risk
Subjects received acetylsalicylic acid 100 mg enteric-coated tablet and matching placebo of rivaroxaban orally once daily (OD).
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Antiphospholipid syndrome
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
60/3562 • Number of events 60 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
1.7%
60/3559 • Number of events 60 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial tachycardia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Amnesia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Intracardiac thrombus
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac flutter
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Fabry's disease
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Congenital, familial and genetic disorders
Factor V Leiden mutation
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Diabetic retinopathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Episcleritis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Eyelid ptosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Keratitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Pterygium
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.14%
5/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.20%
7/3559 • Number of events 7 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.22%
8/3562 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip swelling
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.14%
5/3562 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Retching
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Palatal disorder
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Discomfort
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Biliary colic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Diarrhoea infectious
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia viral
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Lung infection
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Alveolar osteitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Inappropriate schedule of drug administration
|
0.03%
1/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication error
|
0.28%
10/3562 • Number of events 10 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.25%
9/3559 • Number of events 9 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Drug administration error
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.17%
6/3562 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Labelled drug-drug interaction medication error
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin wound
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Incorrect dosage administered
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Medication monitoring error
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Intentional product misuse
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Coagulation factor VIII level increased
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Heart rate increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Visual acuity tests abnormal
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Transaminases increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Haemochromatosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dementia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.14%
5/3562 • Number of events 6 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.20%
7/3559 • Number of events 7 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness postural
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paralysis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.28%
10/3562 • Number of events 10 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.22%
8/3559 • Number of events 9 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Seizure
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Speech disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vertebral artery occlusion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hyposmia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paresis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Stroke in evolution
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Partial seizures
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Autonomic neuropathy
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cerebral artery stenosis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Occipital neuralgia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Impatience
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Abulia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Adjustment disorder
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Post stroke depression
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal colic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Breast mass
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal ulceration
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary microemboli
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.11%
4/3562 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.11%
4/3559 • Number of events 4 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.08%
3/3559 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin swelling
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Social circumstances
Treatment noncompliance
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.14%
5/3559 • Number of events 5 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.06%
2/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Cataract operation
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Implantable cardiac monitor insertion
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.31%
11/3562 • Number of events 11 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.20%
7/3559 • Number of events 8 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertensive crisis
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Intermittent claudication
|
0.03%
1/3562 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Phlebitis superficial
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.06%
2/3559 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Vascular pain
|
0.00%
0/3562 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.06%
2/3562 • Number of events 2 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.03%
1/3559 • Number of events 1 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.08%
3/3562 • Number of events 3 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
0.00%
0/3559 • From start of study drug administration until 2 days after the last dose of study drug, an average of 279 days
Safety analysis set included all randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Global PI to provide to Bayer for review any proposed Publication/oral presentation relating to Study/Study Drug/Results at least 20 days prior to submission or presentation of the Publication. Abstracts/posters/oral presentations to be provided to Bayer 5 working days before Publication/presentation. Bayer may provide comments within the applicable period. Under certain circumstances Bayer may request a further delay of publications to avoid adverse effects on a Bayer patent application.
- Publication restrictions are in place
Restriction type: OTHER