Trial Outcomes & Findings for Comparing the Efficacy of Tiotropium + Olodaterol (5/5 µg) Fixed Dose Combination (FDC) Over Tiotropium 5µg in Reducing Moderate to Severe Exacerbations in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease. (NCT NCT02296138)
NCT ID: NCT02296138
Last Updated: 2018-06-04
Results Overview
Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7903 participants
Primary outcome timeframe
From first in-take of study medication until 1 day after last in-take of study medication, up to 361 days
Results posted on
2018-06-04
Participant Flow
A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.
Following informed consent, the patient was entered into a maximum 7-day screening period to confirm the patient's eligibility. At Visit 2, after a successful review of the inclusion and exclusion criteria, the patient was randomly allocated in equal ratio to receive once daily trial treatment and then entered the 360 days treatment phase.
Participant milestones
| Measure |
Tiotropium 5 Microgram (μg)
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Overall Study
STARTED
|
3952
|
3951
|
|
Overall Study
Treated
|
3941
|
3939
|
|
Overall Study
COMPLETED
|
3291
|
3451
|
|
Overall Study
NOT COMPLETED
|
661
|
500
|
Reasons for withdrawal
| Measure |
Tiotropium 5 Microgram (μg)
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
348
|
259
|
|
Overall Study
Lack of Efficacy
|
59
|
37
|
|
Overall Study
Protocol Violation
|
35
|
36
|
|
Overall Study
Lost to Follow-up
|
9
|
12
|
|
Overall Study
Withdrawal by Subject
|
184
|
131
|
|
Overall Study
Not Treated
|
1
|
1
|
|
Overall Study
Patients with data irregularities
|
10
|
11
|
|
Overall Study
Other than specified
|
15
|
13
|
Baseline Characteristics
Treated Set
Baseline characteristics by cohort
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 Participants
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 Participants
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Total
n=7880 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.3 Years
STANDARD_DEVIATION 8.5 • n=5 Participants • Treated Set
|
66.5 Years
STANDARD_DEVIATION 8.4 • n=7 Participants • Treated Set
|
66.4 Years
STANDARD_DEVIATION 8.5 • n=5 Participants • Treated Set
|
|
Sex: Female, Male
Female
|
1100 Participants
n=5 Participants • Treated Set
|
1154 Participants
n=7 Participants • Treated Set
|
2254 Participants
n=5 Participants • Treated Set
|
|
Sex: Female, Male
Male
|
2841 Participants
n=5 Participants • Treated Set
|
2785 Participants
n=7 Participants • Treated Set
|
5626 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
64 Participants
n=5 Participants • Treated Set
|
77 Participants
n=7 Participants • Treated Set
|
141 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Asian
|
607 Participants
n=5 Participants • Treated Set
|
557 Participants
n=7 Participants • Treated Set
|
1164 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
5 Participants
n=5 Participants • Treated Set
|
3 Participants
n=7 Participants • Treated Set
|
8 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants • Treated Set
|
58 Participants
n=7 Participants • Treated Set
|
110 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
White
|
3113 Participants
n=5 Participants • Treated Set
|
3134 Participants
n=7 Participants • Treated Set
|
6247 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=5 Participants • Treated Set
|
22 Participants
n=7 Participants • Treated Set
|
42 Participants
n=5 Participants • Treated Set
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
80 Participants
n=5 Participants • Treated Set
|
88 Participants
n=7 Participants • Treated Set
|
168 Participants
n=5 Participants • Treated Set
|
PRIMARY outcome
Timeframe: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 daysPopulation: Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.
Annualised rate of moderate to severe COPD exacerbations during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. Least Squares Means are actually exponentiated.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 Participants
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 Participants
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Annualised Rate of Moderate to Severe COPD Exacerbations During the Actual Treatment Period.
|
0.97 Rate per patient-year
Interval 0.9 to 1.03
|
0.90 Rate per patient-year
Interval 0.84 to 0.96
|
SECONDARY outcome
Timeframe: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 daysPopulation: Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.
Key secondary endpoint: Number of patients with at least one moderate to severe COPD exacerbation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation is presented.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 Participants
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 Participants
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Number of Patients With at Least One Moderate to Severe COPD Exacerbation During the Actual Treatment Period.
|
1777 Number of patients
|
1746 Number of patients
|
SECONDARY outcome
Timeframe: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 daysPopulation: Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.
Annualised rate of exacerbations leading to hospitalisation during the actual treatment period was calculated per treatment per patient-year. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 Participants
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 Participants
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Annualised Rate of Exacerbations Leading to Hospitalisation During the Actual Treatment Period.
|
0.20 Rate per patient-year
Interval 0.18 to 0.22
|
0.18 Rate per patient-year
Interval 0.16 to 0.2
|
SECONDARY outcome
Timeframe: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 daysPopulation: Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.
Number of patients with at least one COPD exacerbation leading to hospitalisation during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with at least one moderate to severe COPD exacerbation leading to hospitalisation is presented.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 Participants
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 Participants
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Number of Patients With at Least One COPD Exacerbation Leading to Hospitalisation During the Actual Treatment Period.
|
469 Number of patients
|
450 Number of patients
|
SECONDARY outcome
Timeframe: From first in-take of study medication until 1 day after last in-take of study medication, up to 361 daysPopulation: Treated set (TS) -This patient set includes all randomised patients who were documented to have taken at least 1 dose of trial medication.
Number of patients with all-cause mortality occurring during the actual treatment period per treatment. The actual treatment period was defined as the interval from first in-take of study medication until 1 day after last in-take of study medication. The median was not estimated due to less than 50% of patients having an event. Hence the number of patients with all-cause mortality is presented.
Outcome measures
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 Participants
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 Participants
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Number of Patients With All-cause Mortality Occurring During the Actual Treatment Period.
|
32 Number of patients
|
36 Number of patients
|
Adverse Events
Tiotropium 5 Microgram (μg)
Serious events: 862 serious events
Other events: 1786 other events
Deaths: 98 deaths
Tiotropium (5 μg) + Olodaterol (5 μg)
Serious events: 810 serious events
Other events: 1770 other events
Deaths: 92 deaths
Serious adverse events
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 participants at risk
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 participants at risk
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Cardiac disorders
Cardiopulmonary failure
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Accelerated idioventricular rhythm
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.23%
9/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.28%
11/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Angina pectoris
|
0.20%
8/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Angina unstable
|
0.36%
14/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.15%
6/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Aortic valve disease mixed
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Arrhythmia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Atrial fibrillation
|
0.30%
12/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.46%
18/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Atrial flutter
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Bradycardia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiac arrest
|
0.20%
8/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.20%
8/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiac failure
|
0.53%
21/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.58%
23/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiac failure acute
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.13%
5/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.36%
14/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.43%
17/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.15%
6/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cardiomyopathy
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cor pulmonale
|
0.13%
5/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Coronary artery disease
|
0.28%
11/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.20%
8/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Heart valve incompetence
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Left ventricular failure
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Microvascular coronary artery disease
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Myocardial haemorrhage
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Myocardial infarction
|
0.33%
13/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.25%
10/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Prinzmetal angina
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Right ventricular failure
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Sinoatrial block
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Sinus arrest
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Tachycardia
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Congenital, familial and genetic disorders
Porokeratosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Congenital, familial and genetic disorders
Retinal anomaly congenital
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Congenital, familial and genetic disorders
Syringomyelia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Acute vestibular syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Deafness
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Age-related macular degeneration
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Cataract
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Cataract subcapsular
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Gaze palsy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Glaucoma
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Macular degeneration
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Macular fibrosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Macular hole
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Open angle glaucoma
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Retinal tear
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Eye disorders
Retinal vein thrombosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Colitis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Constipation
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Enteritis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Food poisoning
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Gastritis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Haematemesis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Haematochezia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Melaena
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Necrotising colitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Subileus
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Volvulus
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Gastrointestinal disorders
Vomiting
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Chest pain
|
0.28%
11/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.25%
10/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Death
|
0.36%
14/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Hyperplasia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Impaired healing
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Incarcerated hernia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Malaise
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Medical device site haematoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Medical device site pain
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.15%
6/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Oedema
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Pain
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Peripheral swelling
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Pyrexia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Sudden cardiac death
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Sudden death
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
General disorders
Vascular stent restenosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Cholangitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Immune system disorders
Anaphylactic shock
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Acinetobacter infection
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Bacterial sepsis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Botulism
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Bronchitis
|
0.18%
7/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Bronchitis bacterial
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Cellulitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Chronic sinusitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Chronic tonsillitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Colon gangrene
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Diverticulitis
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Empyema
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Endocarditis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Gastroenteritis
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Giardiasis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Herpes zoster
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Infected skin ulcer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Infective exacerbation of bronchiectasis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.38%
15/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.38%
15/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Infective glossitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Influenza
|
0.25%
10/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Intestinal gangrene
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Lung abscess
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Lung infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Neurosyphilis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Neutropenic sepsis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Oral bacterial infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Peritonitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pneumonia
|
3.7%
144/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
3.4%
132/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pneumonia bacterial
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Post procedural infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Postoperative abscess
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Psoas abscess
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pulmonary sepsis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pyelonephritis acute
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Respiratory tract infection
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Rotavirus infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Sepsis
|
0.25%
10/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.23%
9/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Septic arthritis staphylococcal
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Septic shock
|
0.13%
5/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Strongyloidiasis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Tracheobronchitis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Urinary tract infection
|
0.30%
12/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Urosepsis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Viral infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Infections and infestations
Wound infection
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Anastomotic stenosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Brain herniation
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Fall
|
0.30%
12/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.25%
10/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Nail injury
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Occupational exposure to product
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Petroleum distillate poisoning
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Suture rupture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Urinary retention postoperative
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Blood lactic acid increased
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Blood pressure increased
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Breath sounds absent
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Liver function test increased
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
PCO2 increased
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Troponin increased
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Investigations
Weight decreased
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Electrolyte depletion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Cartilage hypertrophy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.15%
6/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.15%
6/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.25%
10/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
5/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellopontine angle tumour
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ear neoplasm
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.15%
6/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung infiltration malignant
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.18%
7/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.33%
13/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphocytic leukaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to adrenals
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic lymphoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucoepidermoid carcinoma of salivary gland
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral haemangioma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penis carcinoma metastatic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer metastatic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
8/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.20%
8/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal neoplasm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal adenoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasm
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Acoustic neuritis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Alcohol induced persisting dementia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Amnesia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Anterior interosseous syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.18%
7/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.20%
8/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Coma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Dementia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Dizziness
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Epilepsy
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Facial neuralgia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Headache
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Hemianaesthesia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Hemiparesis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Loss of consciousness
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Mononeuropathy
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Monoplegia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Myelopathy
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Nerve root compression
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Presyncope
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Quadriparesis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Seizure
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Syncope
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Transient global amnesia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Tremor
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Product Issues
Device breakage
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Product Issues
Device lead damage
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Product Issues
Device malfunction
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Alcohol abuse
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Anxiety
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Brief psychotic disorder with marked stressors
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Completed suicide
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Delirium
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Depression
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Major depression
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Mental disorder
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Panic attack
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.18%
7/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.38%
15/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Calculus urinary
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Renal colic
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Renal failure
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Renal salt-wasting syndrome
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Urethral fistula
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Renal and urinary disorders
Urinary retention
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.61%
24/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.53%
21/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis allergic
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
10.3%
405/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
10.0%
394/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.28%
11/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.15%
6/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Lung consolidation
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
8/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.13%
5/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
9/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.23%
9/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.13%
5/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.28%
11/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.10%
4/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.10%
4/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.1%
43/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.84%
33/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Surgical and medical procedures
Enterostomy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Surgical and medical procedures
Gallbladder operation
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Surgical and medical procedures
Lung transplant
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Surgical and medical procedures
Pancreatic operation
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Aortic aneurysm
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Aortic thrombosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Arterial disorder
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Arteriosclerosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Brachiocephalic arteriosclerosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Circulatory collapse
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
8/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Embolism
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Haematoma
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Hypertension
|
0.13%
5/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Hypertensive crisis
|
0.23%
9/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.15%
6/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Hypotension
|
0.05%
2/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Intermittent claudication
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Ischaemia
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Macroangiopathy
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Microscopic polyangiitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Orthostatic hypotension
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.08%
3/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.05%
2/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Phlebitis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Subclavian artery occlusion
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Subgaleal haematoma
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.00%
0/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.03%
1/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Vascular disorders
Thrombosis
|
0.03%
1/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
0.08%
3/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
Other adverse events
| Measure |
Tiotropium 5 Microgram (μg)
n=3941 participants at risk
Patient received 5 μg Tiotropium inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
Tiotropium (5 μg) + Olodaterol (5 μg)
n=3939 participants at risk
Patient received 5 μg Tiotropium + 5 μg Olodaterol fixed-dose combination (FDC) inhalation solution - RESPIMAT inhaler once daily orally for 360 days
|
|---|---|---|
|
Infections and infestations
Viral upper respiratory tract infection
|
7.4%
293/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
7.1%
281/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
38.2%
1504/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
38.6%
1519/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
232/3941 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
5.2%
203/3939 • From the first dose of trial medication until 21 days after last in-take of trial medication, up to 381 days
Safety analyses were based on the treated set, which included all randomised patients who took at least 1 dose of trial medication during the randomised treatment period. Patients were only actively requested to report adverse events during the on-treatment period.
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER