Trial Outcomes & Findings for Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities (NCT NCT02504216)
NCT ID: NCT02504216
Last Updated: 2020-12-08
Results Overview
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
6564 participants
Primary outcome timeframe
For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.
Results posted on
2020-12-08
Participant Flow
Study was conducted at 548 centers which screened participants (534 sites randomized participants) worldwide between 18 Aug 2015 (first patient's first visit) and 27 Nov 2019 (last patient's last visit).
A total of 6772 participants were screened, of which 6564 were randomly assigned to either of the two treatment arms.
Participant milestones
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Overall Study
STARTED
|
3286
|
3278
|
|
Overall Study
Received Treatment
|
3256
|
3248
|
|
Overall Study
COMPLETED
|
3275
|
3263
|
|
Overall Study
NOT COMPLETED
|
11
|
15
|
Reasons for withdrawal
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
12
|
Baseline Characteristics
Efficacy and Safety of Rivaroxaban in Reducing the Risk of Major Thrombotic Vascular Events in Subjects With Symptomatic Peripheral Artery Disease Undergoing Peripheral Revascularization Procedures of the Lower Extremities
Baseline characteristics by cohort
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
Total
n=6564 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.0 Years
n=5 Participants
|
67.0 Years
n=7 Participants
|
67 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
847 Participants
n=5 Participants
|
857 Participants
n=7 Participants
|
1704 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2439 Participants
n=5 Participants
|
2421 Participants
n=7 Participants
|
4860 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
484 Participants
n=5 Participants
|
482 Participants
n=7 Participants
|
966 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
84 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
155 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2647 Participants
n=5 Participants
|
2656 Participants
n=7 Participants
|
5303 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
69 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For each participant, the first occurrence of the composite primary efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean time in follow-up survival time until ECOD that date was 1109.76 days.Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Primary Efficacy Outcome: Number of Participants With Composite of Myocardial Infarction (MI), Ischemic Stroke, Cardiovascular Death, Acute Limb Ischemia (ALI) and Major Amputation Due to a Vascular Etiology
|
508 Participants
|
584 Participants
|
PRIMARY outcome
Timeframe: For each participant, the first occurrence of the primary safety outcome after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).Population: Safety analysis set (SAF Set): Comprised all treated participants, i.e. randomized participants who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3256 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3248 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Primary Safety Outcome: Number of Participants With TIMI (Thrombolysis in Myocardial Infarction) Major Bleeding
|
62 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.79 days.Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Participants With Composite of MI, Ischemic Stroke, Coronary Heart Disease (CHD) Death, ALI, and Major Amputation of a Vascular Etiology
|
433 Participants
|
528 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1062.48 days.Population: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Participants With an Unplanned Index Limb Revascularization for Recurrent Limb Ischemia (Subsequent Index Leg Revascularization That Was Not Planned or Considered as Part of the Initial Treatment Plan at the Time of Randomization)
|
584 Participants
|
655 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1154.04 daysPopulation: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Participants With Hospitalization for a Coronary or Peripheral Cause (Either Lower Limb) of a Thrombotic Nature
|
262 Participants
|
356 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1085.13 daysPopulation: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Participants With Composite of MI, Ischemic Stroke, All-cause Mortality (ACM), ALI, and Major Amputation of a Vascular Etiology
|
614 Participants
|
679 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the composite efficacy outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1108.29 daysPopulation: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Participants With Composite of MI, All-cause Stroke, Cardiovascular (CV) Death, Acute Limb Ischemia (ALI), and Major Amputation of a Vascular Etiology
|
514 Participants
|
588 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1188.48 daysPopulation: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Mortality (All-cause)
|
321 Participants
|
297 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the outcome after randomization up until the efficacy cut-off date (08-Sep-2019) was considered. The mean survival time until ECOD was 1187.65 daysPopulation: Intention-to-treat analysis set (ITT Set): Comprised all randomized participants.
Venous thromboembolic events were reported by investigator only.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3286 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3278 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Number of Participants With Venous Thromboembolic (VTE) Events
|
25 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the major bleeding events according to the ISTH classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo).Population: Safety analysis set (SAF Set): Comprised all treated participants, i.e. randomized participants who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered.
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3256 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3248 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Secondary Safety Outcome: Number of Participants With ISTH (International Society on Thrombosis and Haemostasis) Major Bleeding
|
140 Participants
|
100 Participants
|
SECONDARY outcome
Timeframe: For each participant, the first occurrence of the type 3b and above bleeding events according to the BARC classification after randomization up until 2 days after permanent stop of study drug (rivaroxaban or rivaroxaban placebo)Population: Safety analysis set (SAF Set): Comprised all treated participants, i.e. randomized participants who received at least one dose of study drug (rivaroxaban or rivaroxaban placebo).
Only the first occurrence of the outcome event under analysis within the data scope from a participant is considered
Outcome measures
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3256 Participants
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3248 Participants
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Secondary Safety Outcome: Number of Participants With BARC (Bleeding Academic Research Consortium) Type 3b and Above Bleeding Events
|
93 Participants
|
73 Participants
|
Adverse Events
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
Serious events: 948 serious events
Other events: 725 other events
Deaths: 327 deaths
Rivaroxaban Placebo Bid + Aspirin 100 mg od
Serious events: 927 serious events
Other events: 729 other events
Deaths: 304 deaths
Serious adverse events
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3256 participants at risk
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3248 participants at risk
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign laryngeal neoplasm
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer stage IV
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Central nervous system lymphoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myelomonocytic leukaemia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Follicular thyroid cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage I
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage II
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma recurrent
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary serous endometrial carcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage I
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage IV
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to neck
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer stage IV
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell carcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the oral cavity
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of the tongue
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-cell lymphoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal cancer metastatic
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.25%
8/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Ligament disorder
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Bone loss
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.43%
14/3256 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Systemic scleroderma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Angina pectoris
|
0.31%
10/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Angina unstable
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Aortic valve stenosis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Arrhythmia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.58%
19/3256 • Number of events 19 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.62%
20/3248 • Number of events 21 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrioventricular block complete
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Bradycardia
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac arrest
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac failure
|
0.43%
14/3256 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 15 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac failure acute
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac failure chronic
|
0.18%
6/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac failure congestive
|
0.31%
10/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac tamponade
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiogenic shock
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Coronary artery disease
|
0.46%
15/3256 • Number of events 18 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.65%
21/3248 • Number of events 21 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Coronary artery stenosis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cyanosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Myocardial infarction
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Myocardial ischaemia
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Sinus arrest
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Ventricular tachycardia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
1/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Acute left ventricular failure
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Congenital, familial and genetic disorders
Congenital bladder neck obstruction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Ear and labyrinth disorders
Deafness
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Endocrine disorders
Goitre
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Endocrine disorders
Thyroid mass
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Cataract
|
0.25%
8/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Cataract subcapsular
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Diabetic retinopathy
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Glaucoma
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Macular degeneration
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Macular oedema
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Myopia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Retinal detachment
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Vitreous haemorrhage
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Macular hole
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Detachment of macular retinal pigment epithelium
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Vitreoretinal traction syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Macular detachment
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.09%
3/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Anal stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Colitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Constipation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Crohn's disease
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Dental alveolar anomaly
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Dysphagia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Ileus
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Intestinal angina
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Intestinal ulcer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Periodontal disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Subileus
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.31%
10/3256 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Pancreatic duct stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal incarcerated hernia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Asthenia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Chest discomfort
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Chest pain
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Crepitations
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Death
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Gait disturbance
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Granuloma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Hernia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Impaired healing
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Oedema
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Oedema peripheral
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Pain
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Pyrexia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Peripheral swelling
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
General physical health deterioration
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Puncture site haemorrhage
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Systemic inflammatory response syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Organ failure
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Inflammation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Drug intolerance
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Non-cardiac chest pain
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Stent-graft endoleak
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Vascular stent occlusion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Vascular stent stenosis
|
0.34%
11/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Vascular device occlusion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
3/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Steatohepatitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Primary biliary cholangitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Abscess
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Appendicitis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Arteriosclerotic gangrene
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Blister infected
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Bronchitis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Carbuncle
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Cellulitis
|
0.58%
19/3256 • Number of events 19 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.55%
18/3248 • Number of events 20 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Cellulitis gangrenous
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Clostridium difficile colitis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Cystitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Diabetic gangrene
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Diarrhoea infectious
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Diverticulitis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Ear infection
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Eczema infected
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Endocarditis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Erysipelas
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Fournier's gangrene
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Fungal cystitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Fungal skin infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Gangrene
|
0.49%
16/3256 • Number of events 18 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.62%
20/3248 • Number of events 22 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Gastroenteritis
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Infected skin ulcer
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Influenza
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Localised infection
|
0.58%
19/3256 • Number of events 19 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Lymphangitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Mastoiditis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Oesophageal candidiasis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Orchitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Osteomyelitis
|
0.34%
11/3256 • Number of events 15 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Osteomyelitis chronic
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Otitis media
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Perinephric abscess
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Periodontitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Peritonitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pharyngitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pneumonia
|
1.2%
40/3256 • Number of events 49 • From randomization until 2 days following permanent discontinuation of the study drug
|
1.4%
45/3248 • Number of events 50 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Postoperative wound infection
|
0.83%
27/3256 • Number of events 28 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.77%
25/3248 • Number of events 26 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pseudomembranous colitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pyelonephritis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Sepsis
|
0.37%
12/3256 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Septic shock
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Skin infection
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Subcutaneous abscess
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Tonsillitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Urinary tract infection
|
0.40%
13/3256 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Wound infection
|
0.52%
17/3256 • Number of events 19 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.46%
15/3248 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Urosepsis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Scrotal abscess
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Groin abscess
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Abscess limb
|
0.18%
6/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Groin infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Lymph gland infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Periumbilical abscess
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Burn infection
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Haematoma infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pulmonary sepsis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Perineal abscess
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Abdominal infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Graft infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Gastric infection
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.09%
3/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Infected lymphocele
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Intervertebral discitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Diabetic foot infection
|
0.03%
1/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pneumonia bacterial
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Arthritis infective
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Extradural abscess
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Soft tissue infection
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Respiratory tract infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Cholecystitis infective
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Device related infection
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Cystitis bacterial
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Dermo-hypodermitis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Post procedural sepsis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Superinfection bacterial
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Post procedural infection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Bone abscess
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Infected seroma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Medical device site infection
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Medical device site joint infection
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Perineal cellulitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Vascular device infection
|
0.06%
2/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Complicated appendicitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Concussion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.31%
10/3256 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Head injury
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Injury
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Penetrating abdominal trauma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Seroma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Underdose
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Chemical burn of skin
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.06%
2/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Cerebral hyperperfusion syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.12%
4/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.49%
16/3256 • Number of events 22 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.46%
15/3248 • Number of events 18 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Skin scar contracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular graft restenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Arterial bypass stenosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Blood glucose increased
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Blood potassium increased
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Blood pressure increased
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Cardiovascular function test abnormal
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Cystoscopy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Immunoglobulins decreased
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Carbohydrate antigen 19-9 increased
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Hepatic enzyme increased
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Vascular test
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Dehydration
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hyperglycaemic hyperosmolar nonketotic syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Bone disorder
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Bone formation increased
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Jaw cyst
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle disorder
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.43%
14/3256 • Number of events 18 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 15 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
2/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Tendon disorder
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.18%
6/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spondyloarthropathy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Vertebral column mass
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Acquired claw toe
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thymoma malignant
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Respiratory tract neoplasm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease stage IV
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gingival cancer
|
0.03%
1/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Inflammatory pseudotumour
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenolymphoma
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma metastatic
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ductal adenocarcinoma of pancreas
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant genitourinary tract neoplasm
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm papilla of Vater
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal adenocarcinoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin squamous cell carcinoma recurrent
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Carotid artery stenosis
|
0.68%
22/3256 • Number of events 23 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.74%
24/3248 • Number of events 26 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Dementia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Diabetic neuropathy
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Dizziness
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Dizziness postural
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Drop attacks
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Epilepsy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Mental impairment
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Myelopathy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Nerve compression
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Parkinsonism
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Presyncope
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Sciatica
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Somnolence
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Spinal claudication
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Status epilepticus
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Syncope
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Tension headache
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Tonic convulsion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Vertebral artery stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Facial paresis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Ischaemic neuropathy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Restless legs syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Putamen haemorrhage
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Carotid artery disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Vascular encephalopathy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Pseudoradicular syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Brain injury
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Colloid brain cyst
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Sacral radiculopathy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Alcoholism
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Completed suicide
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Depression
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Drug abuse
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Intentional self-injury
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Organic brain syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Mental status changes
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Transient psychosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Calculus bladder
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Renal colic
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Renal failure
|
0.18%
6/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Ureteric fistula
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Urinary incontinence
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Urinary retention
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Renal impairment
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Urethral stenosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Acute kidney injury
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.52%
17/3248 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
End stage renal disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Spermatocele
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Vulvar dysplasia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Vulval eczema
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
16/3256 • Number of events 23 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.12%
4/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.03%
1/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.15%
5/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
3/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal lesion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar cyst
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Acute interstitial pneumonitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Pemphigus
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.31%
10/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Myxoid cyst
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Social circumstances
Disease risk factor
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Bladder calculus removal
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Blepharoplasty
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Foot amputation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Vitrectomy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Radical prostatectomy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Transurethral bladder resection
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Peripheral revascularisation
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Brain tumour operation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Cystoprostatectomy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Amputation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Bladder polypectomy
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Limb reconstructive surgery
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Peripheral artery stent insertion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Eventration repair
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Aortic aneurysm
|
0.06%
2/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Aortic dissection
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Aortic stenosis
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Circulatory collapse
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Haematoma
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypertension
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypertensive crisis
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypotension
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Intermittent claudication
|
1.3%
43/3256 • Number of events 51 • From randomization until 2 days following permanent discontinuation of the study drug
|
1.6%
52/3248 • Number of events 58 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral ischaemia
|
1.0%
34/3256 • Number of events 44 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.89%
29/3248 • Number of events 46 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral vascular disorder
|
0.09%
3/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Poor peripheral circulation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Renovascular hypertension
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Temporal arteritis
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Varicose vein
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Lymphocele
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Dry gangrene
|
0.06%
2/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Lymphorrhoea
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Iliac artery stenosis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Vascular stenosis
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral artery occlusion
|
0.21%
7/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypertensive emergency
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypertensive urgency
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Venous occlusion
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Angiopathy
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Extremity necrosis
|
0.37%
12/3256 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral embolism
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
3.8%
125/3256 • Number of events 156 • From randomization until 2 days following permanent discontinuation of the study drug
|
4.0%
130/3248 • Number of events 182 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Arterial occlusive disease
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Ischaemic limb pain
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Lymphatic fistula
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral artery stenosis
|
0.77%
25/3256 • Number of events 29 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral venous disease
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Product Issues
Device breakage
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Product Issues
Device dislocation
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Product Issues
Device occlusion
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Product Issues
Patient-device incompatibility
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Product Issues
Device battery issue
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
Other adverse events
| Measure |
Rivaroxaban 2.5 mg Bid + Aspirin 100 mg od
n=3256 participants at risk
Participants were treated with Rivaroxaban 2.5 mg twice-daily (bid) and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily (od)
|
Rivaroxaban Placebo Bid + Aspirin 100 mg od
n=3248 participants at risk
Participants were treated with Rivaroxaban-placebo twice-daily and aspirin (ASA: Acetylsalicylic Acid) 100 mg once-daily
|
|---|---|---|
|
General disorders
Chest discomfort
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Chest pain
|
0.34%
11/3256 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.49%
16/3248 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Fatigue
|
0.34%
11/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Gait disturbance
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Impaired healing
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Oedema peripheral
|
0.49%
16/3256 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.62%
20/3248 • Number of events 21 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Peripheral swelling
|
0.28%
9/3256 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Non-cardiac chest pain
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Vascular stent stenosis
|
0.28%
9/3256 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Immune system disorders
Hypersensitivity
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Bronchitis
|
0.46%
15/3256 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.52%
17/3248 • Number of events 21 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Cellulitis
|
0.31%
10/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Gangrene
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Herpes zoster
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Influenza
|
0.31%
10/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Localised infection
|
0.34%
11/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Nasopharyngitis
|
0.64%
21/3256 • Number of events 23 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.92%
30/3248 • Number of events 32 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Osteomyelitis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Pneumonia
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Postoperative wound infection
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Sinusitis
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Upper respiratory tract infection
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Urinary tract infection
|
0.68%
22/3256 • Number of events 23 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.65%
21/3248 • Number of events 27 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Wound infection
|
0.28%
9/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Respiratory tract infection viral
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Infections and infestations
Respiratory tract infection
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Fall
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Contusion
|
0.28%
9/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.34%
11/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.15%
5/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Blood pressure increased
|
0.12%
4/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Investigations
Haemoglobin decreased
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Gout
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.40%
13/3256 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.55%
18/3256 • Number of events 19 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.99%
32/3248 • Number of events 37 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.71%
23/3256 • Number of events 25 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.92%
30/3248 • Number of events 33 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.15%
5/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.15%
5/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.40%
13/3256 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.31%
10/3256 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.37%
12/3256 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
47/3256 • Number of events 58 • From randomization until 2 days following permanent discontinuation of the study drug
|
1.6%
52/3248 • Number of events 53 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Carotid artery stenosis
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Diabetic neuropathy
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Dizziness
|
0.71%
23/3256 • Number of events 27 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.80%
26/3248 • Number of events 28 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Headache
|
0.55%
18/3256 • Number of events 20 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.58%
19/3248 • Number of events 21 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.18%
6/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Neuropathy peripheral
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Paraesthesia
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Sciatica
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Nervous system disorders
Syncope
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Delirium
|
0.00%
0/3256 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Psychiatric disorders
Depression
|
0.34%
11/3256 • Number of events 12 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Dysuria
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Haematuria
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Renal failure
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Renal impairment
|
0.12%
4/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.25%
8/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Renal and urinary disorders
Acute kidney injury
|
0.21%
7/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.25%
8/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.43%
14/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.34%
11/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.46%
15/3248 • Number of events 15 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.28%
9/3256 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.15%
5/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.31%
10/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.49%
16/3256 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.55%
18/3248 • Number of events 20 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.49%
16/3256 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.55%
18/3248 • Number of events 18 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Tooth extraction
|
0.18%
6/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Surgical and medical procedures
Cataract operation
|
0.15%
5/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypertension
|
1.5%
49/3256 • Number of events 54 • From randomization until 2 days following permanent discontinuation of the study drug
|
1.5%
50/3248 • Number of events 56 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypertensive crisis
|
0.34%
11/3256 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 15 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Hypotension
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Intermittent claudication
|
1.2%
39/3256 • Number of events 48 • From randomization until 2 days following permanent discontinuation of the study drug
|
1.3%
43/3248 • Number of events 48 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral ischaemia
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral vascular disorder
|
0.18%
6/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Dry gangrene
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral artery occlusion
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.37%
12/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Extremity necrosis
|
0.18%
6/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
1.0%
34/3256 • Number of events 45 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.95%
31/3248 • Number of events 37 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Vascular disorders
Peripheral artery stenosis
|
0.40%
13/3256 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.89%
29/3256 • Number of events 29 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.71%
23/3248 • Number of events 23 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.25%
8/3256 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Angina pectoris
|
0.28%
9/3256 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrial fibrillation
|
0.95%
31/3256 • Number of events 33 • From randomization until 2 days following permanent discontinuation of the study drug
|
1.5%
48/3248 • Number of events 49 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Atrial flutter
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Cardiac failure
|
0.09%
3/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.22%
7/3248 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Coronary artery disease
|
0.37%
12/3256 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Myocardial ischaemia
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.03%
1/3248 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Palpitations
|
0.09%
3/3256 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Cardiac disorders
Sinus tachycardia
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Ear and labyrinth disorders
Tinnitus
|
0.12%
4/3256 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.34%
11/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Cataract
|
0.43%
14/3256 • Number of events 17 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.28%
9/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Eye disorders
Diabetic retinopathy
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.18%
6/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.09%
3/3248 • Number of events 3 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.18%
6/3248 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.58%
19/3256 • Number of events 19 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.46%
15/3248 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Constipation
|
0.34%
11/3256 • Number of events 11 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Diarrhoea
|
0.71%
23/3256 • Number of events 24 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.68%
22/3248 • Number of events 22 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.00%
0/3248 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Dyspepsia
|
0.46%
15/3256 • Number of events 16 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastritis
|
0.46%
15/3256 • Number of events 15 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.06%
2/3256 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
8/3256 • Number of events 8 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.25%
8/3248 • Number of events 9 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.12%
4/3256 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.06%
2/3248 • Number of events 2 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.03%
1/3256 • Number of events 1 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.15%
5/3248 • Number of events 5 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Nausea
|
0.43%
14/3256 • Number of events 14 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.31%
10/3248 • Number of events 10 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
7/3256 • Number of events 7 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.40%
13/3248 • Number of events 13 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
|
General disorders
Asthenia
|
0.18%
6/3256 • Number of events 6 • From randomization until 2 days following permanent discontinuation of the study drug
|
0.12%
4/3248 • Number of events 4 • From randomization until 2 days following permanent discontinuation of the study drug
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER