Trial Outcomes & Findings for Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I) (NCT NCT00249795)
NCT ID: NCT00249795
Last Updated: 2010-10-15
Results Overview
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
9016 participants
Primary outcome timeframe
Median follow-up of 4.5 years
Results posted on
2010-10-15
Participant Flow
Patients were enrolled in 567 centers in 33 countries. They were initially to be followed until November 2008. After a blinded reassessment of the event rate in May 2008, the planned follow-up end date was postponed and was actually completed on August 2009 corresponding to an actual median follow-up of 4.5 years.
Participant milestones
| Measure |
Irbesartan
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
matching placebo up to final follow-up visit
|
|---|---|---|
|
Overall Study
STARTED
|
4518
|
4498
|
|
Overall Study
COMPLETED
|
3124
|
3108
|
|
Overall Study
NOT COMPLETED
|
1394
|
1390
|
Reasons for withdrawal
| Measure |
Irbesartan
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
matching placebo up to final follow-up visit
|
|---|---|---|
|
Overall Study
Not treated
|
16
|
14
|
|
Overall Study
Symptomatic hypotension
|
127
|
64
|
|
Overall Study
Other Serious Adverse Event
|
84
|
93
|
|
Overall Study
Qualifying condition not present
|
26
|
29
|
|
Overall Study
Withdrawal by Subject
|
678
|
742
|
|
Overall Study
Thromboembolic / outcome event
|
39
|
45
|
|
Overall Study
Oral anticoagulant required
|
2
|
0
|
|
Overall Study
Minor bleeding (e.g.,bruising,epistaxis)
|
7
|
3
|
|
Overall Study
Non-compliance
|
71
|
69
|
|
Overall Study
Study drug intolerance
|
3
|
3
|
|
Overall Study
Other adverse events (non-serious)
|
188
|
159
|
|
Overall Study
Physician withdrew consent
|
71
|
63
|
|
Overall Study
Surgery / procedure
|
4
|
5
|
|
Overall Study
Angiotensin II receptor blocker required
|
35
|
58
|
|
Overall Study
Lightheadedness / dizziness
|
15
|
11
|
|
Overall Study
Hypotension (non-symptomatic)
|
5
|
5
|
|
Overall Study
Other contraindicated medication
|
1
|
1
|
|
Overall Study
Event related to cardiac condition
|
17
|
16
|
|
Overall Study
Patient not wish to continue after May08
|
4
|
6
|
|
Overall Study
Site not agree to continue after May08
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Missing
|
0
|
1
|
Baseline Characteristics
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE I)
Baseline characteristics by cohort
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
Total
n=9016 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
69.5 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
69.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Age, Customized
18 to <65 years
|
1287 participants
n=5 Participants
|
1255 participants
n=7 Participants
|
2542 participants
n=5 Participants
|
|
Age, Customized
65 to <75 years
|
1684 participants
n=5 Participants
|
1673 participants
n=7 Participants
|
3357 participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
1547 participants
n=5 Participants
|
1570 participants
n=7 Participants
|
3117 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1773 Participants
n=5 Participants
|
1768 Participants
n=7 Participants
|
3541 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2745 Participants
n=5 Participants
|
2730 Participants
n=7 Participants
|
5475 Participants
n=5 Participants
|
|
Congestive heart failure, High blood pressure, Age, Diabetes Stroke 2 (CHADS2) Score
0
|
103 participants
n=5 Participants
|
96 participants
n=7 Participants
|
199 participants
n=5 Participants
|
|
Congestive heart failure, High blood pressure, Age, Diabetes Stroke 2 (CHADS2) Score
1
|
1687 participants
n=5 Participants
|
1678 participants
n=7 Participants
|
3365 participants
n=5 Participants
|
|
Congestive heart failure, High blood pressure, Age, Diabetes Stroke 2 (CHADS2) Score
2
|
1516 participants
n=5 Participants
|
1560 participants
n=7 Participants
|
3076 participants
n=5 Participants
|
|
Congestive heart failure, High blood pressure, Age, Diabetes Stroke 2 (CHADS2) Score
> 2
|
1210 participants
n=5 Participants
|
1163 participants
n=7 Participants
|
2373 participants
n=5 Participants
|
|
Congestive heart failure, High blood pressure, Age, Diabetes Stroke 2 (CHADS2) Score
Missing
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Sitting Systolic Blood Pressure
<120 mmHg
|
509 participants
n=5 Participants
|
500 participants
n=7 Participants
|
1009 participants
n=5 Participants
|
|
Sitting Systolic Blood Pressure
>=120 mmHg
|
4006 participants
n=5 Participants
|
3996 participants
n=7 Participants
|
8002 participants
n=5 Participants
|
|
Sitting Systolic Blood Pressure
Missing
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
29.129 kg/m²
STANDARD_DEVIATION 5.614 • n=5 Participants
|
28.867 kg/m²
STANDARD_DEVIATION 5.420 • n=7 Participants
|
28.998 kg/m²
STANDARD_DEVIATION 5.519 • n=5 Participants
|
|
ACTIVE A / ACTIVE W
ACTIVE A: clopidogrel + ASA
|
1263 participants
n=5 Participants
|
1231 participants
n=7 Participants
|
2494 participants
n=5 Participants
|
|
ACTIVE A / ACTIVE W
ACTIVE A: ASA
|
1245 participants
n=5 Participants
|
1259 participants
n=7 Participants
|
2504 participants
n=5 Participants
|
|
ACTIVE A / ACTIVE W
ACTIVE W: clopidogrel + ASA
|
1011 participants
n=5 Participants
|
959 participants
n=7 Participants
|
1970 participants
n=5 Participants
|
|
ACTIVE A / ACTIVE W
ACTIVE W: OAC
|
999 participants
n=5 Participants
|
1049 participants
n=7 Participants
|
2048 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for all analyses. This consisted of all randomized patients irrespective of whether or not the patient actually received study drug or the patient's compliance with the study protocol. All patients were included in the treatment group to which they were originally allocated.
The first co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal) or vascular death - after validation by the Event Adjudication Committee (EAC).
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
All components
|
963 participants
|
963 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
- Myocardial Infarction (fatal or not)
|
136 participants
|
123 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
- Stroke (fatal or not)
|
367 participants
|
407 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke or Vascular Death as Per Adjudication
- Vascular death
|
460 participants
|
433 participants
|
PRIMARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for this analysis.
The second co-primary event is the first occurence of any component of the following cluster over the duration of follow-up: myocardial infarction (nonfatal or fatal), stroke (nonfatal or fatal), vascular death or hospitalization for heart failure - after validation by the EAC.
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
All components
|
1236 participants
|
1291 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
- Myocardial Infarction (fatal or not)
|
122 participants
|
112 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
- Stroke (fatal or not)
|
340 participants
|
375 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
- Vascular death
|
331 participants
|
291 participants
|
|
First Occurence of Any Component of the Composite of Myocardial Infarction, Stroke, Vascular Death or Hospitalization for Heart Failure as Per Adjudication
- Hospitalization for heart failure
|
443 participants
|
513 participants
|
SECONDARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for this analysis.
The considered event is the first occurrence of stroke (nonfatal or fatal, ischemic, hemorrhagic or of uncertain type) over the duration of follow-up, after validation by the EAC.
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
First Occurrence of Stroke
|
379 participants
|
411 participants
|
SECONDARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for the analysis.
The considered event is the death over the duration of the follow-up whatever the cause, cardiovascular or non-cardiovascular.
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
Death From Any Cause
|
949 participants
|
929 participants
|
SECONDARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for the analysis.
The considered event is the first occurence of any HF episode defined as evidence of signs and symptoms of HF with or without hospitalization over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
First Occurrence of Any Heart Failure (HF) Episode
|
699 participants
|
767 participants
|
SECONDARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for this analysis.
The considered event is the first overnight hospital stay for HF over the duration of the follow-up, after validation by the EAC.
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
First Hospitalisation for Heart Failure (HF)
|
482 participants
|
551 participants
|
SECONDARY outcome
Timeframe: Median follow-up of 4.5 yearsPopulation: The intent-to-treat (ITT) population was used for the analysis.
The considered event is the overnight hospital stay for any CV cause other than Heart Failure over the duration of follow-up, as reported by the investigator (i.e. not validated by the Event Adjudication Committee).
Outcome measures
| Measure |
Irbesartan
n=4518 Participants
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 Participants
matching placebo up to final follow-up visit
|
|---|---|---|
|
First Hospitalisation for Other Cardiovascular (CV) Cause
|
1186 participants
|
1174 participants
|
Adverse Events
Irbesartan
Serious events: 1409 serious events
Other events: 3303 other events
Deaths: 0 deaths
Placebo
Serious events: 1446 serious events
Other events: 3277 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Irbesartan
n=4518 participants at risk
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 participants at risk
matching placebo up to final follow-up visit
|
|---|---|---|
|
Injury, poisoning and procedural complications
Poisoning
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Post procedural stroke
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinal vein thrombosis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia
|
3.1%
141/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
3.7%
167/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Urinary tract infection
|
0.62%
28/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.58%
26/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bronchitis
|
0.58%
26/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.51%
23/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Sepsis
|
0.44%
20/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.62%
28/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Accidental poisoning
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Gastroenteritis
|
0.42%
19/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.44%
20/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bronchopneumonia
|
0.35%
16/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.40%
18/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Cellulitis
|
0.29%
13/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.47%
21/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Appendicitis
|
0.22%
10/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Diverticulitis
|
0.22%
10/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Septic shock
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.29%
13/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Erysipelas
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.27%
12/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Respiratory tract infection
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Viral infection
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Lung infection
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Urosepsis
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Postoperative wound infection
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Infection
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Haematoma infection
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Lobar pneumonia
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Influenza
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pyelonephritis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Wound infection
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pyelonephritis acute
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Clostridial infection
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Tracheobronchitis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Gangrene
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Herpes zoster
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Post procedural infection
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bronchiectasis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Arthritis infective
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bacteraemia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Device related infection
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pulmonary sepsis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Endocarditis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Lung infection pseudomonal
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Skin infection
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Osteomyelitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Anal abscess
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Cystitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Labyrinthitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Subcutaneous abscess
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Vestibular neuronitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Necrotising fasciitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Orchitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Post procedural sepsis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Sinusitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Acarodermatitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Acute sinusitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Acute tonsillitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Anogenital warts
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Arthritis bacterial
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Beta haemolytic streptococcal infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Biliary tract infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bronchitis bacterial
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Diarrhoea infectious
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Encephalitis viral
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Enterocolitis infectious
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Escherichia infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Eye infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Gastroenteritis viral
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Gastrointestinal infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Genitourinary tract infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Hepatitis e
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Infected skin ulcer
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Injection site infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Intervertebral discitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Perirectal abscess
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Peritoneal infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia escherichia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia klebsiella
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia legionella
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Skin bacterial infection
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Staphylococcal toxaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Tetanus
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Tuberculosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Vulval abscess
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Localised infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Gallbladder empyema
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Borrelia infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Breast abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Cholangitis suppurative
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Diabetic foot infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Diabetic gangrene
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Empyema
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Fungal sepsis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Meningitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Nosocomial infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Parotitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pharyngeal abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Splenic abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.58%
26/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.60%
27/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.44%
20/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.60%
27/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.44%
20/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.33%
15/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.35%
16/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.36%
16/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.24%
11/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastritis
|
0.22%
10/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.27%
12/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.22%
10/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.27%
12/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.15%
7/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Ileus
|
0.15%
7/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.22%
10/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Vomiting
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Constipation
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Peritonitis
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Ascites
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Diverticulum
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Food poisoning
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Nausea
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Volvulus
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Subileus
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Duodenitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intra-abdominal haematoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Umbilical hernia, obstructive
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Enteritis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric mucosal lesion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric perforation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Hernial eventration
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Mallory-weiss syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Megacolon
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Mesenteric occlusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Polyp colorectal
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Swollen tongue
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Tooth loss
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Colonic pseudo-obstruction
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastric disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Lumbar hernia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Radicular cyst
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Sigmoiditis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.62%
28/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.76%
34/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.42%
19/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.40%
18/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.40%
18/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.33%
15/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.33%
15/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.22%
10/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.22%
10/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer metastatic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute leukaemia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage iv
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm prostate
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign anorectal neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm malignant
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the stomach
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystosarcoma phyllodes
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diaphragm neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibrosarcoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer stage iv
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma multiforme
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymph node cancer metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic renal cell carcinoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurofibroma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neuroendocrine tumour
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer metastatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute lymphocytic leukaemia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of adrenal gland
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Biliary cancer metastatic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour pulmonary
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic leukaemia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage ii
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage iv
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Duodenal neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer metastatic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangiopericytoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna stage unspecified
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer stage iii
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sarcoma uterus
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vascular neoplasm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
26/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.53%
24/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.35%
16/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.64%
29/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.35%
16/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.38%
17/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.31%
14/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.31%
14/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.31%
14/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.24%
11/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Therapeutic agent toxicity
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.15%
7/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.20%
9/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Operative haemorrhage
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Drug toxicity
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Injury
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.20%
9/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Dislocation of joint prosthesis
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Open fracture
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Fractured coccyx
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Radiation mucositis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Anastomotic leak
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Back crushing
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Device failure
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Dural tear
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Epiphyseal fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Complication of device insertion
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Heat exhaustion
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Postoperative adhesion
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Pubic rami fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.00%
45/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.89%
40/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.46%
21/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.44%
20/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.31%
14/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.22%
10/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.20%
9/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.22%
10/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.15%
7/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.27%
12/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial disorder
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Foreign body aspiration
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosa atrophy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary amyloidosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hilum mass
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
58/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
1.1%
48/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.24%
11/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Kyphoscoliosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Sympathetic posterior cervical syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Arthritis enteropathic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Senile ankylosing vertebral hyperostosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Senile osteoporosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Vertebral wedging
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal failure acute
|
0.77%
35/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.42%
19/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal failure
|
0.58%
26/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.29%
13/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Haematuria
|
0.24%
11/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.24%
11/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.15%
7/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urinary retention
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.20%
9/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal cyst
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal colic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Calculus urinary
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Anuria
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Bladder neck obstruction
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Calculus bladder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Obstructive uropathy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Polyuria
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Bladder stenosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Cystitis ulcerative
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urethral fistula
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Urethral meatus stenosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Syncope
|
0.49%
22/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.58%
26/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.29%
13/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.62%
28/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.29%
13/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Dizziness
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.24%
11/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Dementia alzheimer's type
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Dementia
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Presyncope
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Convulsion
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.22%
10/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Polyneuropathy
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Sciatica
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cervical root pain
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Loss of consciousness
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Epilepsy
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Encephalopathy
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Aphasia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Vascular dementia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Headache
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Dizziness postural
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Encephalitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Intercostal neuralgia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Ageusia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Anosmia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Brachial plexopathy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Brain injury
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cerebellar syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cerebral haematoma
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Hypokinesia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Paraesthesia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Simple partial seizures
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Intracranial haematoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Paresis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Mental impairment
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Myxoedema coma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Optic neuritis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Postictal paralysis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Radicular syndrome
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.64%
29/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.49%
22/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.33%
15/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.40%
18/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.15%
7/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.36%
16/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Jaundice
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Biliary colic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatitis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholangitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholelithiasis obstructive
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cholestasis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Liver disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Post cholecystectomy syndrome
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hepatosplenomegaly
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Hepatobiliary disorders
Hydrocholecystis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Hypotension
|
0.33%
15/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Haemorrhage
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Haematoma
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Hypertension
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Aortic aneurysm
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.18%
8/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Bleeding varicose vein
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Thrombophlebitis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Varicose vein
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Peripheral ischaemia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Arteriosclerosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Arteriosclerosis obliterans
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Deep vein thrombosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Vasculitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Aneurysm
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Circulatory collapse
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Extremity necrosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Hypoperfusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Iliac vein occlusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Orthostatic hypotension
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Peripheral embolism
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Temporal arteritis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Thrombosed varicose vein
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Venous thrombosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Wound haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Haemorrhagic infarction
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Aneurysm arteriovenous
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Arterial disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Venous insufficiency
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.33%
15/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.27%
12/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Gout
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
6/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Haemosiderosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Neuroglycopenia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Underweight
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.53%
24/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.47%
21/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Prostatism
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Colpocele
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Fibrocystic breast disease
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Genital prolapse
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Uterine cervical erosion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Prostatic disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Prostatic haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Reproductive system and breast disorders
Varicocele
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.38%
17/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.27%
12/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Anaemia megaloblastic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Anaemia of chronic disease
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Anaemia vitamin b12 deficiency
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Chest pain
|
0.20%
9/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
General physical health deterioration
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Non-cardiac chest pain
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.16%
7/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Asthenia
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Hernia obstructive
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Pyrexia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Multi-organ failure
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Oedema peripheral
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Gait disturbance
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Hernia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Generalised oedema
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Malaise
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Catheter site pain
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Chest discomfort
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Implant site effusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Swelling
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Pain
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Catheter thrombosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Death
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Drowning
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Fat tissue increased
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Hyperplasia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Hypertrophy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Perforated ulcer
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Cataract
|
0.38%
17/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.40%
18/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Glaucoma
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Eye haemorrhage
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Vitreous haemorrhage
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinal detachment
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinal haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Diplopia
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Episcleritis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Pupils unequal
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinal artery occlusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinal disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinal vascular thrombosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Retinoschisis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Eye disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Visual impairment
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Depression
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.13%
6/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Confusional state
|
0.09%
4/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Completed suicide
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Mental status changes
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Suicide attempt
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Psychotic disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Alcohol abuse
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Stress
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Alcoholism
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Delusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Delusional disorder, persecutory type
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Depression suicidal
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Major depression
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Mental disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Somatisation disorder
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Delusional disorder, unspecified type
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Neurosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Paranoia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Schizophrenia, paranoid type
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Pustular psoriasis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Acanthosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.22%
10/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Goitre
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.07%
3/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Hypothyroidism
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Hyperaldosteronism
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Hyperparathyroidism secondary
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.18%
8/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.20%
9/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Ear and labyrinth disorders
Vertigo labyrinthine
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Atrial fibrillation
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Bradycardia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Atrioventricular block
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Mitral valve disease
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Pericardial effusion
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Right ventricular failure
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Dressler's syndrome
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.11%
5/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.09%
4/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Muscular dystrophy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Adenomatous polyposis coli
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Congenital, familial and genetic disorders
Bicuspid aortic valve
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Hospitalisation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Colon operation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Haemorrhoid operation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Retinal operation
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Wound drainage
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Dacryocystorhinostomy
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Eventration procedure
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Intestinal stoma
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Intraocular lens repositioning
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Surgical and medical procedures
Renal cyst excision
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
International normalised ratio increased
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.11%
5/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Haemoglobin decreased
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.07%
3/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Weight decreased
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Aspiration bronchial
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Blood glucose increased
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Prostatic specific antigen increased
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Immune system disorders
Hypersensitivity
|
0.04%
2/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.04%
2/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.02%
1/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.00%
0/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Social circumstances
Bedridden
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Social circumstances
Elderly
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Social circumstances
Social stay hospitalisation
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Social circumstances
Walking disability
|
0.00%
0/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
0.02%
1/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
Other adverse events
| Measure |
Irbesartan
n=4518 participants at risk
150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
|
Placebo
n=4498 participants at risk
matching placebo up to final follow-up visit
|
|---|---|---|
|
Infections and infestations
Any infections and infestations
|
30.3%
1369/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
30.4%
1369/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Bronchitis
|
5.6%
255/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
5.6%
251/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
225/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
5.3%
238/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Any nervous system disorders
|
23.6%
1067/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
20.4%
917/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Nervous system disorders
Dizziness
|
11.7%
529/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
8.9%
399/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Gastrointestinal disorders
Any gastrointestinal disorders
|
23.1%
1044/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
23.5%
1059/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Musculoskeletal and connective tissue disorders
Any musculoskeletal and connective tissue disorders
|
19.6%
884/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
20.7%
930/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Any general disorders and administration site conditions
|
18.5%
836/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
19.1%
858/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
General disorders
Oedema peripheral
|
5.7%
259/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
6.7%
302/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Any vascular disorders
|
17.4%
784/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
15.3%
686/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Hypotension
|
7.7%
350/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
4.3%
193/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Vascular disorders
Hypertension
|
4.6%
209/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
6.1%
273/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Any respiratory, thoracic and mediastinal disorders
|
17.1%
772/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
17.4%
782/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
333/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
7.3%
330/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Injury, poisoning and procedural complications
Any injury, poisoning and procedural complications
|
12.6%
569/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
12.9%
582/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Skin and subcutaneous tissue disorders
Any skin and subcutaneous tissue disorders
|
10.3%
464/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
10.3%
465/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Cardiac disorders
Any cardiac disorders
|
9.8%
444/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
10.1%
455/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Metabolism and nutrition disorders
Any metabolism and nutrition disorders
|
8.5%
383/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
8.5%
384/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Eye disorders
Any eye disorders
|
7.6%
345/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
7.5%
336/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Renal and urinary disorders
Any renal and urinary disorders
|
7.6%
344/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
6.3%
282/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
6.6%
296/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
8.0%
358/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Investigations
Any investigations
|
6.1%
276/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
6.6%
297/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
|
Psychiatric disorders
Any psychiatric disorders
|
5.8%
260/4518 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
6.1%
275/4498 • From randomization until 14 days after treatment discontinuation or final follow-up visit whichever come first.
The safety analysis was also carried out on the intent-to-treat (ITT) population to allow a benefit/risk assessment within the same study population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the study will be made jointly in the name of all wholehearted collaborators. Other papers will be authored based on the contributions of the individuals to the overall study. Substudies with scientific merit which have received prior approval from the Steering Committee (SC) may be published in the names of the contributing investigators. A copy of all manuscripts will be provided to the sponsors for their review. The final decision to publish articles will be made by the SC.
- Publication restrictions are in place
Restriction type: OTHER