Trial Outcomes & Findings for Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes (NCT NCT01720446)
NCT ID: NCT01720446
Last Updated: 2019-06-27
Results Overview
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3297 participants
Primary outcome timeframe
Time from randomisation up to end of follow-up (scheduled at week 109)
Results posted on
2019-06-27
Participant Flow
The trial was conducted at 229 sites in 20 countries. Country (sites): Algeria (4), Argentina (7), Australia (8), Brazil (8), Bulgaria (5), Canada (13), Denmark (5), Germany (7), Israel (6), Italy (6), Malaysia (6), Mexico (9), Poland (5), Russia (11), Spain (6), Taiwan (4), Thailand (5), Turkey (10), United Kingdom (8) and United States (96).
Subjects could be anti-glycaemic drug naïve, or treated with 1 or 2 oral anti diabetic drugs (OADs), or treated with human NPH insulin or long-acting insulin analogue or pre-mixed insulin, alone or in combination with 1 or 2 OAD(s).
Participant milestones
| Measure |
Semaglutide 0.5 mg
Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Semaglutide 1.0 mg
Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
826
|
822
|
824
|
825
|
|
Overall Study
Premature Treatment Discontinuers
|
164
|
186
|
151
|
159
|
|
Overall Study
COMPLETED
|
812
|
811
|
804
|
805
|
|
Overall Study
NOT COMPLETED
|
14
|
11
|
20
|
20
|
Reasons for withdrawal
| Measure |
Semaglutide 0.5 mg
Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Semaglutide 1.0 mg
Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
12
|
6
|
16
|
16
|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
4
|
4
|
Baseline Characteristics
Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Semaglutide 0.5 mg
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Semaglutide 1.0 mg
n=822 Participants
Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Total
n=3297 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
50-64 years
|
440 participants
n=99 Participants
|
415 participants
n=107 Participants
|
419 participants
n=206 Participants
|
425 participants
n=7 Participants
|
1699 participants
n=31 Participants
|
|
Age, Customized
65-74 years
|
312 participants
n=99 Participants
|
324 participants
n=107 Participants
|
324 participants
n=206 Participants
|
317 participants
n=7 Participants
|
1277 participants
n=31 Participants
|
|
Age, Customized
75-84 years
|
71 participants
n=99 Participants
|
76 participants
n=107 Participants
|
75 participants
n=206 Participants
|
79 participants
n=7 Participants
|
301 participants
n=31 Participants
|
|
Age, Customized
85 and over
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
6 participants
n=206 Participants
|
4 participants
n=7 Participants
|
20 participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
331 Participants
n=99 Participants
|
304 Participants
n=107 Participants
|
342 Participants
n=206 Participants
|
318 Participants
n=7 Participants
|
1295 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
495 Participants
n=99 Participants
|
518 Participants
n=107 Participants
|
482 Participants
n=206 Participants
|
507 Participants
n=7 Participants
|
2002 Participants
n=31 Participants
|
|
Glycosylated haemoglobin
|
8.67 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.39 • n=99 Participants
|
8.73 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.51 • n=107 Participants
|
8.70 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.49 • n=206 Participants
|
8.70 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.45 • n=7 Participants
|
8.70 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.46 • n=31 Participants
|
|
Fasting plasma glucose
|
185.4 mg/dL
STANDARD_DEVIATION 66.09 • n=99 Participants
|
182.9 mg/dL
STANDARD_DEVIATION 68.04 • n=107 Participants
|
185.8 mg/dL
STANDARD_DEVIATION 68.23 • n=206 Participants
|
184.6 mg/dL
STANDARD_DEVIATION 63.08 • n=7 Participants
|
184.7 mg/dL
STANDARD_DEVIATION 66.37 • n=31 Participants
|
|
Body weight
|
91.80 kg
STANDARD_DEVIATION 20.25 • n=99 Participants
|
92.86 kg
STANDARD_DEVIATION 21.05 • n=107 Participants
|
91.83 kg
STANDARD_DEVIATION 20.35 • n=206 Participants
|
91.90 kg
STANDARD_DEVIATION 20.75 • n=7 Participants
|
92.09 kg
STANDARD_DEVIATION 20.60 • n=31 Participants
|
|
LDL-cholesterol
|
89.62 mg/dL
STANDARD_DEVIATION 39.08 • n=99 Participants
|
89.72 mg/dL
STANDARD_DEVIATION 34.49 • n=107 Participants
|
89.01 mg/dL
STANDARD_DEVIATION 38.35 • n=206 Participants
|
91.14 mg/dL
STANDARD_DEVIATION 37.90 • n=7 Participants
|
89.87 mg/dL
STANDARD_DEVIATION 37.49 • n=31 Participants
|
|
HDL-cholesterol
|
45.92 mg/dL
STANDARD_DEVIATION 13.00 • n=99 Participants
|
44.97 mg/dL
STANDARD_DEVIATION 12.42 • n=107 Participants
|
45.82 mg/dL
STANDARD_DEVIATION 12.92 • n=206 Participants
|
44.61 mg/dL
STANDARD_DEVIATION 12.26 • n=7 Participants
|
45.33 mg/dL
STANDARD_DEVIATION 12.66 • n=31 Participants
|
|
Systolic BP
|
136.1 mmHg
STANDARD_DEVIATION 17.97 • n=99 Participants
|
135.8 mmHg
STANDARD_DEVIATION 16.96 • n=107 Participants
|
135.8 mmHg
STANDARD_DEVIATION 16.16 • n=206 Participants
|
134.8 mmHg
STANDARD_DEVIATION 17.45 • n=7 Participants
|
135.6 mmHg
STANDARD_DEVIATION 17.15 • n=31 Participants
|
|
Diastolic BP
|
77.10 mmHg
STANDARD_DEVIATION 9.78 • n=99 Participants
|
76.88 mmHg
STANDARD_DEVIATION 10.21 • n=107 Participants
|
77.54 mmHg
STANDARD_DEVIATION 9.85 • n=206 Participants
|
76.66 mmHg
STANDARD_DEVIATION 10.21 • n=7 Participants
|
77.05 mmHg
STANDARD_DEVIATION 10.02 • n=31 Participants
|
|
Pulse rate
|
72.69 beats/min
STANDARD_DEVIATION 11.22 • n=99 Participants
|
71.53 beats/min
STANDARD_DEVIATION 10.86 • n=107 Participants
|
72.01 beats/min
STANDARD_DEVIATION 10.62 • n=206 Participants
|
71.95 beats/min
STANDARD_DEVIATION 10.92 • n=7 Participants
|
72.05 beats/min
STANDARD_DEVIATION 10.91 • n=31 Participants
|
|
Total cholesterol
|
165.38 mg/dL
n=99 Participants
|
164.96 mg/dL
n=107 Participants
|
164.38 mg/dL
n=206 Participants
|
165.97 mg/dL
n=7 Participants
|
165.17 mg/dL
n=31 Participants
|
|
Triglycerides
|
163.66 mg/dL
n=99 Participants
|
158.93 mg/dL
n=107 Participants
|
162.30 mg/dL
n=206 Participants
|
163.00 mg/dL
n=7 Participants
|
161.96 mg/dL
n=31 Participants
|
|
Free fatty acids
|
0.83 mmol/L
n=99 Participants
|
0.80 mmol/L
n=107 Participants
|
0.83 mmol/L
n=206 Participants
|
0.81 mmol/L
n=7 Participants
|
0.82 mmol/L
n=31 Participants
|
PRIMARY outcome
Timeframe: Time from randomisation up to end of follow-up (scheduled at week 109)Population: Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.
Percentage of subjects experiencing a first event of a major adverse cardiovascular event (MACE), defined as cardiovascular (CV) death, non-fatal myocardial infarction (MI), or non-fatal stroke.
Outcome measures
| Measure |
Semaglutide
n=1648 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=1649 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Time From Randomisation to First Occurrence of a MACE, Defined as Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke
|
6.6 percentage of subjects
|
8.9 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomisation up to end of follow-up (scheduled at week 109)Population: Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.
Percentage of subjects experiencing first occurrence of an expanded composite CV outcome (defined as either MACE, revascularisation \[coronary and peripheral\], unstable angina requiring hospitalisation or hospitalisation for heart failure)
Outcome measures
| Measure |
Semaglutide
n=1648 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=1649 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Time From Randomisation to First Occurrence of an Expanded Composite Cardiovascular Outcome
|
12.1 percentage of subjects
|
16.0 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomisation up to end of follow-up (scheduled at week 109)Population: Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.
Percentage of subjects experiencing an event onset for each individual component of the expanded composite cardiovascular outcomes (defined as either MACE, revascularisation \[coronary and peripheral\], unstable angina requiring hospitalisation or hospitalisation for heart failure).
Outcome measures
| Measure |
Semaglutide
n=1648 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=1649 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Cardiovascular death
|
1.6 percentage of subjects
|
1.9 percentage of subjects
|
—
|
—
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Non-fatal MI
|
2.5 percentage of subjects
|
3.7 percentage of subjects
|
—
|
—
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Non-fatal Stroke
|
1.5 percentage of subjects
|
2.5 percentage of subjects
|
—
|
—
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Revascularisation
|
2.6 percentage of subjects
|
4.2 percentage of subjects
|
—
|
—
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
UAP requiring hospitalisation
|
1.1 percentage of subjects
|
1.3 percentage of subjects
|
—
|
—
|
|
Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome
Hospitalisation for heart failure
|
2.7 percentage of subjects
|
2.4 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Time from randomisation up to end of follow-up (scheduled at week 109)Population: Full analysis set included all the randomised subjects. As specified in the protocol, the two semaglutide dose arms (semaglutide 0.5 mg + semaglutide 1.0 mg) and the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.
Percentage of subjects experiencing a first occurrence of all-cause death, non-fatal MI, or non-fatal stroke.
Outcome measures
| Measure |
Semaglutide
n=1648 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=1649 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Time From Randomisation to First Occurrence of All-cause Death, Non-fatal MI, or Non-fatal Stroke
|
7.4 percentage of subjects
|
9.6 percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all the randomised subjects
Estimated mean change from baseline in glycosylated haemoglobin (HbA1c) to last assessment in the trial during the treatment period.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Glycosylated Haemoglobin (HbA1c)
|
-1.09 percentage of glycosylated haemoglobin
Standard Error 0.05
|
-1.41 percentage of glycosylated haemoglobin
Standard Error 0.05
|
-0.44 percentage of glycosylated haemoglobin
Standard Error 0.05
|
-0.36 percentage of glycosylated haemoglobin
Standard Error 0.05
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all the randomised subjects.
Estimated mean change from baseline to last assessment in fasting plasma glucose in the trial during the treatment period.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Fasting Plasma Glucose
|
-1.75 mmol/L
Standard Error 0.12
|
-2.11 mmol/L
Standard Error 0.12
|
-1.02 mmol/L
Standard Error 0.12
|
-0.88 mmol/L
Standard Error 0.12
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all the randomised subjects. As specified in the protocol, the two placebo dose arms (placebo 0.5 mg + placebo 1.0 mg) were pooled for the analysis of this endpoint.
Estimated mean change from baseline to last assessment in body weight in the trial during the treatment period.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=1649 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Body Weight
|
-3.57 kg
Standard Error 0.21
|
-4.88 kg
Standard Error 0.22
|
-0.62 kg
Standard Error 0.15
|
—
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all randomised subjects.
Estimated ratio to baseline at week 104 during the treatment period in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides).
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
Total cholesterol (mg/dL)
|
0.97 mg/dL
Standard Error 0.01
|
0.97 mg/dL
Standard Error 0.01
|
1.00 mg/dL
Standard Error 0.01
|
0.99 mg/dL
Standard Error 0.01
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
HDL-cholesterol (mg/dL)
|
0.99 mg/dL
Standard Error 0.01
|
1.01 mg/dL
Standard Error 0.01
|
0.99 mg/dL
Standard Error 0.01
|
0.97 mg/dL
Standard Error 0.01
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
LDL-cholesterol (mg/dL)
|
0.97 mg/dL
Standard Error 0.01
|
0.98 mg/dL
Standard Error 0.01
|
1.01 mg/dL
Standard Error 0.01
|
0.99 mg/dL
Standard Error 0.01
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile
Triglycerides (mg/dL)
|
0.93 mg/dL
Standard Error 0.01
|
0.92 mg/dL
Standard Error 0.01
|
0.96 mg/dL
Standard Error 0.01
|
0.98 mg/dL
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all the randomised subjects
Estimated ratio to baseline in urinary albumin to creatinine ratio at week 104 during the treatment period.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Urinary Albumin to Creatinine Ratio
|
1.02 mg/g
Standard Error 0.05
|
0.91 mg/g
Standard Error 0.05
|
1.32 mg/g
Standard Error 0.07
|
1.29 mg/g
Standard Error 0.06
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all the randomised subjects.
Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (diastolic blood pressure and systolic blood pressure).
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
Diastolic blood pressure (mmHg)
|
-1.37 mmHg
Standard Error 0.32
|
-1.57 mmHg
Standard Error 0.32
|
-1.42 mmHg
Standard Error 0.32
|
-1.71 mmHg
Standard Error 0.32
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs
Systolic blood pressure (mmHg)
|
-3.44 mmHg
Standard Error 0.54
|
-5.37 mmHg
Standard Error 0.54
|
-2.17 mmHg
Standard Error 0.54
|
-2.78 mmHg
Standard Error 0.54
|
SECONDARY outcome
Timeframe: Week 0 - 109Population: Full analysis set included all randomised subjects.
Rates (event rate per 100 exposure years) of severe or blood glucose confirmed symptomatic hypoglycaemia defned as an episode that was severe according to the American diabetic association (ADA) classification or blood glucose (BG) confirmed by a PG value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Incidence During the Trial in Other Treatment Outcomes: Hypoglycaemic Events
|
37.5 Event rate per 100 exposure years
|
36.2 Event rate per 100 exposure years
|
35.3 Event rate per 100 exposure years
|
39.7 Event rate per 100 exposure years
|
SECONDARY outcome
Timeframe: Weeks 0-109Population: Full analysis set included all randomised subjects.
Rates (event rate per 100 years of exposure) of treatment emergent adverse events.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Incidence During the Trial in Other Treatment Outcomes: Adverse Events
|
330.5 Event rate per 100 years of exposure
|
337.0 Event rate per 100 years of exposure
|
317.4 Event rate per 100 years of exposure
|
298.3 Event rate per 100 years of exposure
|
SECONDARY outcome
Timeframe: Weeks 0-109Population: Full analysis set included all randomised subjects
The percentage of subjects that tested positive for anti-semaglutide antibodies at any time point post-baseline during the trial, from week 0 to week 109.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Occurrence During the Trial in Other Treatment Outcomes: Anti-semaglutide Antibodies
|
1.4 Percentage of subjects
|
2.3 Percentage of subjects
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all randomised subjects.
Estimated mean change from baseline to last assessment in the trial in patient reported outcomes (PRO). PRO questionnaire (SF-36v2TM) measured the individual overall health related quality of life namely bodily pain, general health, mental component summary, mental health, physical component summary, physical functioning, role-emotional, role-physical, social functioning and vitality. The PRO scores were transformed to a 0-100 scale with higher scores indicating greater health related quality of life.
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
General health
|
1.66 Scores on a scale
Standard Error 0.29
|
2.55 Scores on a scale
Standard Error 0.29
|
0.78 Scores on a scale
Standard Error 0.29
|
1.13 Scores on a scale
Standard Error 0.30
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Mental component summary
|
0.0 Scores on a scale
Standard Error 0.35
|
0.86 Scores on a scale
Standard Error 0.35
|
-0.17 Scores on a scale
Standard Error 0.35
|
-0.11 Scores on a scale
Standard Error 0.35
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Mental health
|
0.48 Scores on a scale
Standard Error 0.33
|
1.08 Scores on a scale
Standard Error 0.33
|
-0.14 Scores on a scale
Standard Error 0.33
|
-0.31 Scores on a scale
Standard Error 0.33
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Physical component summary
|
0.76 Scores on a scale
Standard Error 0.28
|
1.74 Scores on a scale
Standard Error 0.28
|
0.07 Scores on a scale
Standard Error 0.28
|
0.35 Scores on a scale
Standard Error 0.28
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Physical functioning
|
0.42 Scores on a scale
Standard Error 0.32
|
1.12 Scores on a scale
Standard Error 0.32
|
-0.38 Scores on a scale
Standard Error 0.32
|
-0.37 Scores on a scale
Standard Error 0.33
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Role-emotional
|
0.17 Scores on a scale
Standard Error 0.42
|
0.89 Scores on a scale
Standard Error 0.42
|
-0.36 Scores on a scale
Standard Error 0.42
|
-0.05 Scores on a scale
Standard Error 0.42
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Role-physical
|
0.39 Scores on a scale
Standard Error 0.34
|
1.18 Scores on a scale
Standard Error 0.35
|
-0.33 Scores on a scale
Standard Error 0.35
|
0.03 Scores on a scale
Standard Error 0.35
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Social functioning
|
-0.25 Scores on a scale
Standard Error 0.35
|
0.97 Scores on a scale
Standard Error 0.35
|
-0.20 Scores on a scale
Standard Error 0.36
|
-0.17 Scores on a scale
Standard Error 0.36
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Vitality
|
0.29 Scores on a scale
Standard Error 0.31
|
1.55 Scores on a scale
Standard Error 0.31
|
-0.04 Scores on a scale
Standard Error 0.31
|
0.35 Scores on a scale
Standard Error 0.31
|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Patient Reported Outcome (PRO)
Bodily pain
|
0.66 Scores on a scale
Standard Error 0.35
|
1.82 Scores on a scale
Standard Error 0.35
|
0.16 Scores on a scale
Standard Error 0.35
|
0.35 Scores on a scale
Standard Error 0.35
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all randomised subjects.
Estimated ratio to baseline at week 104 during the treatment period in lipid profile (free fatty acids).
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Lipid Profile (Free Fatty Acids)
|
0.95 mmol/L
Standard Error 0.02
|
0.91 mmol/L
Standard Error 0.01
|
0.96 mmol/L
Standard Error 0.02
|
0.99 mmol/L
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Week 0, up to week 104Population: Full analysis set included all the randomised subjects.
Estimated mean change from baseline to last assessment in the trial during the treatment period in vital signs (pulse rate).
Outcome measures
| Measure |
Semaglutide
n=826 Participants
Subjects received once-weekly dose of semaglutide 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo
n=822 Participants
Subjects received once-weekly dose of placebo 0.5 mg or 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment and the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 Participants
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 Participants
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Change From Baseline to Last Assessment in the Trial in Other Treatment Outcomes: Vital Signs (Pulse Rate)
|
2.12 beats/min
Standard Error 0.34
|
2.41 beats/min
Standard Error 0.34
|
0.09 beats/min
Standard Error 0.34
|
-0.07 beats/min
Standard Error 0.34
|
Adverse Events
Semaglutide 0.5 mg
Serious events: 289 serious events
Other events: 573 other events
Deaths: 0 deaths
Semaglutide 1.0 mg
Serious events: 276 serious events
Other events: 587 other events
Deaths: 0 deaths
Placebo 0.5 mg
Serious events: 329 serious events
Other events: 547 other events
Deaths: 0 deaths
Placebo 1.0 mg
Serious events: 298 serious events
Other events: 524 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Semaglutide 0.5 mg
n=826 participants at risk
Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Semaglutide 1.0 mg
n=822 participants at risk
Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 participants at risk
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 participants at risk
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Pancreatic enzymes increased
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Homicidal ideation
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Osteomyelitis
|
0.61%
5/826 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Otitis externa
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Ear and labyrinth disorders
Otosclerosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Abdominal hernia repair
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/822 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Abscess limb
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Acute hepatitis B
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
18/826 • Number of events 22 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/822 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.7%
14/824 • Number of events 14 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.7%
22/825 • Number of events 24 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.9%
16/826 • Number of events 21 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.6%
13/822 • Number of events 14 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.8%
15/824 • Number of events 15 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.3%
27/825 • Number of events 28 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Amylase increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
5/826 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Immune system disorders
Anaphylactic shock
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anaplastic astrocytoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Angina pectoris
|
1.1%
9/826 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/822 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.9%
16/824 • Number of events 17 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.5%
12/825 • Number of events 12 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Angina unstable
|
1.6%
13/826 • Number of events 16 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.8%
15/822 • Number of events 18 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.3%
19/824 • Number of events 21 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.7%
22/825 • Number of events 23 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Angioplasty
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Aortic aneurysm
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Aortic stenosis
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Aortic valve disease
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Appendicitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Arrhythmia
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Arteriogram coronary
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Ascites
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Asthenia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
14/826 • Number of events 16 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.5%
12/822 • Number of events 15 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.4%
20/824 • Number of events 22 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.2%
18/825 • Number of events 19 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrial flutter
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Azotaemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell small lymphocytic lymphoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/825 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Bacterial test positive
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Biliary colic
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Bladder trabeculation
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma recurrent
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage II
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Blindness
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Blood glucose fluctuation
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Blood glucose increased
|
0.12%
1/826 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Blood urea increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Boutonneuse fever
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Brachytherapy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Bradycardia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Brain stem infarction
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer in situ
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Bronchitis
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Bundle branch block left
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Calculus urinary
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Campylobacter infection
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac arrest
|
0.61%
5/826 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac asthma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac failure
|
1.2%
10/826 • Number of events 11 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/822 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/824 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac failure acute
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.97%
8/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/824 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac failure congestive
|
2.5%
21/826 • Number of events 31 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.7%
14/822 • Number of events 17 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.8%
15/824 • Number of events 19 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.2%
18/825 • Number of events 21 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac tamponade
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Carotid angioplasty
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Carotid revascularisation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Cataract
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/825 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Cataract cortical
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Cataract nuclear
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Cataract operation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Cellulitis
|
0.73%
6/826 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/824 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/825 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebral infarction
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/824 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/825 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cervical myelopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Chest discomfort
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Chest pain
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/824 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholangitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/824 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Chondrolysis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.2%
10/826 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.7%
14/824 • Number of events 17 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/825 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
3/826 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/824 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/825 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Circulatory collapse
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Colitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Coma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Constipation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/825 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
1.8%
15/826 • Number of events 19 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.97%
8/822 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.1%
17/824 • Number of events 18 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.1%
17/825 • Number of events 19 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.97%
8/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.7%
14/824 • Number of events 14 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/825 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
11/826 • Number of events 11 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/822 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/824 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.85%
7/826 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Coronary revascularisation
|
1.3%
11/826 • Number of events 12 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/822 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.8%
15/824 • Number of events 17 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/825 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Cystitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Cystocele
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Cystoid macular oedema
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Death
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Deep vein thrombosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Dengue fever
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Depression
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Device malfunction
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/824 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Diabetic arthropathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Diabetic cardiomyopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.73%
6/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/825 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Diabetic mononeuropathy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Diabetic retinopathy
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/822 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Diplopia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Diverticulitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Immune system disorders
Drug hypersensitivity
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.73%
6/826 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Dysuria
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Ejection fraction decreased
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Electrocardiogram ST segment abnormal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Electrocardiogram change
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Endocarditis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial sarcoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Enterococcal infection
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Epididymal tenderness
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Epilepsy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Escherichia sepsis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Extremity necrosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Eyelid dermatochalasis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Failure to anastomose
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
11/826 • Number of events 11 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.3%
11/824 • Number of events 11 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.97%
8/825 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Femoral artery occlusion
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Gait disturbance
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder adenocarcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Gallbladder necrosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Gangrene
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastric ileus
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastritis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Gastroenteritis viral
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.61%
5/826 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Generalised oedema
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Glaucoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glomus tumour
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Endocrine disorders
Goitre
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Gout
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Growth hormone-producing pituitary tumour
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Haematoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Haematuria
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Headache
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic adenoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Herpes zoster
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Hospitalisation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Immune system disorders
Hypersensitivity
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Hypertension
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Hypertensive cardiomyopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Hypertensive crisis
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Hypertensive emergency
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Hyperthermia malignant
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Endocrine disorders
Hyperthyroidism
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.85%
7/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/824 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/825 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.61%
5/826 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Hypotension
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Impaired healing
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Implant site infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Incision site infection
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Incorrect dose administered
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Influenza
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Intracranial hypotension
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Ischaemic stroke
|
0.97%
8/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/822 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.9%
16/824 • Number of events 16 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Jaundice
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Labyrinthitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Lacunar infarction
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Laparotomy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Left ventricular failure
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Lipase increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Liver abscess
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Lobar pneumonia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Localised infection
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Macular oedema
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Mechanical ventilation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Mental status changes
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Metaplasia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Microlithiasis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Migraine
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Multi-organ failure
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Myocardial infarction
|
0.48%
4/826 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/822 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/824 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.5%
12/825 • Number of events 14 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.73%
6/826 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Myocarditis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Nasal polypectomy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Necrosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm of appendix
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Nodal arrhythmia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Non-cardiac chest pain
|
0.97%
8/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/822 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.97%
8/824 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Obesity
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Oedema peripheral
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Open angle glaucoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Orthostatic hypotension
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.73%
6/826 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.97%
8/822 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/824 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/825 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraganglion neoplasm
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Parkinsonism
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Paronychia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/825 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Pericardial effusion
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Peripheral artery angioplasty
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Peripheral artery bypass
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Peripheral artery stent insertion
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Peripheral revascularisation
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/824 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/825 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Peritonitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Periumbilical abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Phaeochromocytoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pharyngitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pneumonia
|
2.2%
18/826 • Number of events 19 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.8%
15/822 • Number of events 16 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.7%
22/824 • Number of events 26 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.7%
14/825 • Number of events 14 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Post procedural pneumonia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Postoperative wound infection
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Proctitis haemorrhagic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage I
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage III
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Pterygium operation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.61%
5/825 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pulmonary sepsis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pyelonephritis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pyelonephritis acute
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Pyrexia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Radiculitis lumbosacral
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Removal of internal fixation
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Renal artery arteriosclerosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer stage I
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Renal cyst
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Renal failure
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Renal impairment
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Retinal degeneration
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Retinopathy haemorrhagic
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Right ventricular failure
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.48%
4/825 • Number of events 5 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Schizoaffective disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Seizure
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Sepsis
|
0.85%
7/826 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/825 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Septic shock
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Sinus bradycardia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.36%
3/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Psychiatric disorders
Sleep terror
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Stag horn calculus
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Staphylococcal infection
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Staphylococcal osteomyelitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Stent placement
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Sudden cardiac death
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Sudden death
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Syncope
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.49%
4/822 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/824 • Number of events 4 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/825 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Temporal arteritis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Testicular cyst
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Tooth abscess
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Transaminases increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.85%
7/826 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/822 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/824 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.85%
7/825 • Number of events 7 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Troponin increased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Umbilical hernia repair
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ureteric cancer
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Urinary retention
|
0.24%
2/826 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Urinary tract infection
|
1.1%
9/826 • Number of events 9 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.2%
10/824 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.73%
6/825 • Number of events 6 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Urosepsis
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
VIth nerve disorder
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Vascular parkinsonism
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular asystole
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular hypokinesia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.97%
8/822 • Number of events 8 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Vestibular neuronitis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Viral infection
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Visual field defect
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Vitreous haemorrhage
|
0.24%
2/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.36%
3/822 • Number of events 3 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/825 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Weight decreased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Wound
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Wrong drug administered
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Abdominal sepsis
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Anuria
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Aspergilloma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.24%
2/824 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chondroma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Coagulation time prolonged
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Cor pulmonale acute
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Cranial nerve disorder
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Diabetic end stage renal disease
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Drug intolerance
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Gastritis viral
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Reproductive system and breast disorders
Genital haemorrhage
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive breast carcinoma
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Vascular disorders
Leriche syndrome
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage 0
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Lung cyst
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Injury, poisoning and procedural complications
Near drowning
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Oedema
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Hepatobiliary disorders
Pneumobilia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/825 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Pulmonary valve stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Renal artery stent placement
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Respiratory tract infection
|
0.12%
1/826 • Number of events 2 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Septic encephalopathy
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Speech disorder
|
0.12%
1/826 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Surgical and medical procedures
Tendon sheath incision
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer metastatic
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/822 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/824 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/826 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/822 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.12%
1/824 • Number of events 1 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
0.00%
0/825 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
Other adverse events
| Measure |
Semaglutide 0.5 mg
n=826 participants at risk
Subjects received once-weekly dose of semaglutide 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Semaglutide 1.0 mg
n=822 participants at risk
Subjects received once-weekly dose of semaglutide 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Semaglutide was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 0.5 mg
n=824 participants at risk
Subjects received once-weekly dose of placebo 0.5 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 0.5 mg was achieved after 4 weeks of treatment. Each subject was treated for 104 weeks.
|
Placebo 1.0 mg
n=825 participants at risk
Subjects received once-weekly dose of placebo 1.0 mg as an add-on to their standard-of-care treatment. Injections were administered subcutaneously in the thigh, abdomen or upper arm, at any time of day irrespective of meals. The injections were to be administered on the same weekday during the trial. Placebo was initiated at a dose of 0.25 mg and was escalated (doubled) to 0.5 mg after 4 weeks. Hence the target dose of 1.0 mg was achieved after 8 weeks of treatment. Each subject was treated for 104 weeks.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
45/826 • Number of events 54 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.3%
35/822 • Number of events 40 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.0%
33/824 • Number of events 37 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.8%
31/825 • Number of events 36 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.2%
35/826 • Number of events 37 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.1%
42/822 • Number of events 53 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.3%
19/824 • Number of events 22 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.3%
19/825 • Number of events 33 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Amylase increased
|
3.8%
31/826 • Number of events 39 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.8%
48/822 • Number of events 57 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.4%
28/824 • Number of events 33 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.4%
28/825 • Number of events 33 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
41/826 • Number of events 46 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.0%
33/822 • Number of events 34 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.3%
44/824 • Number of events 46 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.8%
48/825 • Number of events 55 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
41/826 • Number of events 45 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.3%
35/822 • Number of events 40 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
6.9%
57/824 • Number of events 69 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.0%
58/825 • Number of events 70 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.5%
54/826 • Number of events 54 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
6.0%
49/822 • Number of events 58 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.9%
49/824 • Number of events 59 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.8%
48/825 • Number of events 50 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Bronchitis
|
5.6%
46/826 • Number of events 52 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.6%
38/822 • Number of events 43 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.9%
49/824 • Number of events 52 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
6.2%
51/825 • Number of events 64 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Cataract
|
6.7%
55/826 • Number of events 59 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.2%
43/822 • Number of events 48 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.5%
37/824 • Number of events 38 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.5%
45/825 • Number of events 46 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Constipation
|
5.6%
46/826 • Number of events 52 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
9.6%
79/822 • Number of events 97 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.5%
37/824 • Number of events 42 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.4%
36/825 • Number of events 38 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
86/826 • Number of events 97 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
9.1%
75/822 • Number of events 88 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.3%
19/824 • Number of events 21 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.1%
9/825 • Number of events 10 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Eye disorders
Diabetic retinopathy
|
5.6%
46/826 • Number of events 50 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
6.8%
56/822 • Number of events 63 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.7%
39/824 • Number of events 39 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.6%
38/825 • Number of events 43 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.9%
148/826 • Number of events 277 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
18.0%
148/822 • Number of events 245 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
11.8%
97/824 • Number of events 159 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
10.5%
87/825 • Number of events 112 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Dizziness
|
6.4%
53/826 • Number of events 57 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.6%
46/822 • Number of events 54 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.6%
38/824 • Number of events 53 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.6%
38/825 • Number of events 45 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.2%
51/826 • Number of events 68 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.7%
63/822 • Number of events 88 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.8%
23/824 • Number of events 25 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
2.2%
18/825 • Number of events 19 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Nervous system disorders
Headache
|
6.5%
54/826 • Number of events 77 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.1%
58/822 • Number of events 89 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.1%
67/824 • Number of events 114 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
9.0%
74/825 • Number of events 110 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Influenza
|
6.2%
51/826 • Number of events 60 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.8%
48/822 • Number of events 56 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.8%
48/824 • Number of events 57 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.6%
46/825 • Number of events 63 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Investigations
Lipase increased
|
11.4%
94/826 • Number of events 121 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
10.9%
90/822 • Number of events 123 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.0%
66/824 • Number of events 76 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.4%
69/825 • Number of events 83 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
66/826 • Number of events 91 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.3%
60/822 • Number of events 77 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
9.5%
78/824 • Number of events 99 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.0%
66/825 • Number of events 84 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Nausea
|
17.3%
143/826 • Number of events 233 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
21.8%
179/822 • Number of events 282 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.5%
62/824 • Number of events 78 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.0%
66/825 • Number of events 94 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
53/826 • Number of events 59 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
6.2%
51/822 • Number of events 64 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.6%
63/824 • Number of events 75 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.9%
65/825 • Number of events 88 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Infections and infestations
Urinary tract infection
|
9.4%
78/826 • Number of events 108 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.6%
71/822 • Number of events 93 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
7.8%
64/824 • Number of events 97 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
8.2%
68/825 • Number of events 87 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
87/826 • Number of events 128 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
14.8%
122/822 • Number of events 170 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.1%
42/824 • Number of events 51 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.0%
33/825 • Number of events 41 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
36/826 • Number of events 41 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.9%
32/822 • Number of events 33 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.9%
40/824 • Number of events 41 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.6%
46/825 • Number of events 48 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
General disorders
Fatigue
|
2.9%
24/826 • Number of events 27 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.1%
42/822 • Number of events 48 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
1.8%
15/824 • Number of events 16 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.2%
26/825 • Number of events 28 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Renal and urinary disorders
Microalbuminuria
|
3.3%
27/826 • Number of events 30 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
4.0%
33/822 • Number of events 35 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.6%
46/824 • Number of events 51 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.1%
42/825 • Number of events 45 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
38/826 • Number of events 42 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
3.5%
29/822 • Number of events 31 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.6%
46/824 • Number of events 51 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
5.1%
42/825 • Number of events 45 • Adverse events from the first trial-related activity after the subject had signed the informed consent (week -2) until the end of the posttreatment follow-up period (week 109).
Safety was assessed using the full analysis set which included all randomised subjects. Subjects contributed to the evaluation as randomised.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER