Trial Outcomes & Findings for Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure (NCT NCT00853658)
NCT ID: NCT00853658
Last Updated: 2016-11-25
Results Overview
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
7064 participants
Primary outcome timeframe
up to End of Study (78 months)
Results posted on
2016-11-25
Participant Flow
During Active Run-in period, patients received enalapril for step 1 \& 2 and then aliskiren on top of the max tolerated dose of enalapril for step 3. Patients who completed the run in were randomized in a 1:1:1 ratio to one of the 3 treatment arms (aliskiren/enalapril combination therapy, aliskiren monotherapy, or enalapril monotherapy).
Participant milestones
| Measure |
Combination Aliskiren / Enalapril
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
|
Aliskiren
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
Overall Study
STARTED
|
2354
|
2356
|
2354
|
|
Overall Study
Full Analysis Set (FAS)
|
2340
|
2340
|
2336
|
|
Overall Study
Safety Set
|
2347
|
2348
|
2345
|
|
Overall Study
COMPLETED
|
1567
|
1524
|
1539
|
|
Overall Study
NOT COMPLETED
|
787
|
832
|
815
|
Reasons for withdrawal
| Measure |
Combination Aliskiren / Enalapril
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
|
Aliskiren
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
Overall Study
Death
|
713
|
768
|
753
|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
11
|
|
Overall Study
H.A. Request
|
26
|
23
|
19
|
|
Overall Study
IRB request
|
0
|
0
|
2
|
|
Overall Study
Vital Status known (alive) at study end
|
2
|
3
|
3
|
|
Overall Study
Vital Status unknown at study end
|
1
|
1
|
0
|
|
Overall Study
Vital Status at study end N/A
|
8
|
10
|
10
|
|
Overall Study
Patient's request
|
21
|
17
|
11
|
|
Overall Study
Missing study completion information
|
5
|
4
|
6
|
Baseline Characteristics
Efficacy and Safety of Aliskiren and Aliskiren/Enalapril Combination on Morbidity-mortality in Patients With Chronic Heart Failure
Baseline characteristics by cohort
| Measure |
Combination Aliskiren / Enalapril
n=2340 Participants
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
|
Aliskiren
n=2340 Participants
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
n=2336 Participants
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
Total
n=7016 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 11.65 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 12.06 • n=7 Participants
|
63.3 years
STANDARD_DEVIATION 11.71 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 11.81 • n=4 Participants
|
|
Sex: Female, Male
Female
|
494 Participants
n=5 Participants
|
532 Participants
n=7 Participants
|
499 Participants
n=5 Participants
|
1525 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1846 Participants
n=5 Participants
|
1808 Participants
n=7 Participants
|
1837 Participants
n=5 Participants
|
5491 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to End of Study (78 months)Population: Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.
Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF.
Outcome measures
| Measure |
Combination Aliskiren / Enalapril
n=2340 Participants
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
|
Aliskiren
n=2340 Participants
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
n=2336 Participants
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
Primary Composite
|
770 participants
|
791 participants
|
808 participants
|
|
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
CV death
|
512 participants
|
562 participants
|
547 participants
|
|
Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization
1st HF Hospitalization
|
430 participants
|
442 participants
|
452 participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations.
Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Outcome measures
| Measure |
Combination Aliskiren / Enalapril
n=2340 Participants
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
|
Aliskiren
n=2340 Participants
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
n=2336 Participants
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score
|
-5.04 KCCQ Score
Standard Error 0.56
|
-6.03 KCCQ Score
Standard Error 0.57
|
-5.01 KCCQ Score
Standard Error 0.55
|
SECONDARY outcome
Timeframe: up to end of study (78 months)Population: Full Analysis Set (FAS) - All randomized patients with exception of mis-randomized patients that took no study drug and patients from the sites with major GCP violations
Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event.
Outcome measures
| Measure |
Combination Aliskiren / Enalapril
n=2340 Participants
Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
|
Aliskiren
n=2340 Participants
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
n=2336 Participants
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
All Cause Death
|
595 participants
|
654 participants
|
646 participants
|
Adverse Events
Combination of Aliskiren and Enalapril
Serious events: 1466 serious events
Other events: 1698 other events
Deaths: 0 deaths
Aliskiren
Serious events: 1504 serious events
Other events: 1605 other events
Deaths: 0 deaths
Enalapril
Serious events: 1501 serious events
Other events: 1623 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Combination of Aliskiren and Enalapril
n=2347 participants at risk
Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
|
Aliskiren
n=2348 participants at risk
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
n=2345 participants at risk
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
Gastrointestinal disorders
Proctitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Acquired haemophilia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.5%
36/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.2%
28/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.2%
28/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Anaemia vitamin B12 deficiency
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Bicytopenia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Bone marrow infiltration
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.60%
14/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.81%
19/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Hypocoagulable state
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Jaundice acholuric
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Splenic embolism
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.77%
18/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.68%
16/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.1%
49/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.7%
40/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.0%
46/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Adams-Stokes syndrome
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Angina pectoris
|
1.5%
35/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.4%
33/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.6%
37/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Angina unstable
|
2.0%
47/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.0%
48/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.7%
41/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.64%
15/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
3.8%
89/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.2%
98/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.1%
97/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrial flutter
|
0.64%
15/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.89%
21/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrial tachycardia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrioventricular block
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Bifascicular block
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Bradycardia
|
0.51%
12/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Bundle branch block
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Bundle branch block left
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac aneurysm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac arrest
|
2.5%
59/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.6%
61/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.5%
59/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac asthma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac discomfort
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac disorder
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac failure
|
20.5%
480/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
22.2%
521/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
21.4%
503/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
2.3%
54/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.8%
43/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.6%
60/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
5.1%
120/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
5.3%
125/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
5.2%
122/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.2%
76/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.6%
85/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.4%
79/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac hypertrophy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac perforation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac sarcoidosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac valve disease
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac ventricular thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
1.0%
24/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.0%
24/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.85%
20/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
1.3%
31/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.1%
49/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.6%
38/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiomegaly
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Chronotropic incompetence
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
28/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.1%
27/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.94%
22/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Coronary artery insufficiency
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.34%
8/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Extrasystoles
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Left ventricular failure
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Metabolic cardiomyopathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.72%
17/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Mitral valve prolapse
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
56/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.1%
50/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.1%
50/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.81%
19/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.81%
19/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.77%
18/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Nodal rhythm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Palpitations
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Papillary muscle rupture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Pericarditis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Pulseless electrical activity
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Rhythm idioventricular
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Right ventricular failure
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Sinoatrial block
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Sinus node dysfunction
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Supraventricular tachyarrhythmia
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Systolic dysfunction
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Tachycardia
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Tachycardia paroxysmal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Tricuspid valve disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.60%
14/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular dyssynchrony
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.34%
8/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular failure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular fibrillation
|
1.4%
32/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.3%
30/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.4%
34/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular flutter
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular tachyarrhythmia
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.3%
78/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.9%
67/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.7%
63/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Haematotympanum
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Endocrine disorders
Goitre
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Endocrine disorders
Thyrotoxic crisis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Endocrine disorders
Toxic nodular goitre
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Amaurosis fugax
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Amblyopia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Cataract
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Diabetic retinopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Macular hole
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Ocular fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Ocular retrobulbar haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Ophthalmic vein thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinal artery embolism
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinal degeneration
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Retinopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.60%
14/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal strangulated hernia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Acid peptic disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Acute abdomen
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Alcoholic pancreatitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Anal prolapse
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.77%
18/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diverticulum
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Eosinophilic oesophagitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Faecaloma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Femoral hernia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Femoral hernia, obstructive
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.81%
19/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal ischaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal polyp haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Haemorrhagic erosive gastritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.98%
23/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.89%
21/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Intestinal strangulation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Large intestinal stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Mesenteric artery embolism
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Mesenteritis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Oedematous pancreatitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Rectal polyp
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Stress ulcer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Thrombosis mesenteric vessel
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Visceral congestion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Volvulus
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Volvulus of small bowel
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Abasia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Accidental death
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Asthenia
|
0.34%
8/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Brain death
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Cardiac complication associated with device
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Cardiac death
|
2.2%
51/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.9%
68/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.7%
87/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Chest discomfort
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Chest pain
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Death
|
3.2%
75/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.6%
84/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.5%
82/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device battery issue
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device breakage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device defective
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device dislocation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device electrical impedance issue
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device end of service
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device failure
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device inappropriate shock delivery
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device issue
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device lead damage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device lead issue
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device malfunction
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device signal detection issue
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Device stimulation issue
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Disease progression
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Exercise tolerance decreased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Fatigue
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Feeling abnormal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Gait disturbance
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
General physical health deterioration
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Generalised oedema
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Hernia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Hypothermia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Ill-defined disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Impaired healing
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Implant site erosion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Implant site haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Implant site necrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Implant site pain
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Implant site ulcer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Incarcerated hernia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Inflammation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Influenza like illness
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Injury associated with device
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Lead dislodgement
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Localised oedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Malaise
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Medical device complication
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Medical device site thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Metaplasia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Multi-organ failure
|
0.89%
21/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.64%
15/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Necrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.64%
15/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.94%
22/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Oedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Oedema peripheral
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Organ failure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Pyrexia
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Stent-graft endoleak
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Sudden cardiac death
|
1.6%
38/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.7%
39/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.1%
50/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Sudden death
|
4.2%
98/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.8%
89/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.7%
86/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Thrombosis in device
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Ulcer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Undersensing
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Vascular stent restenosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Vascular stent stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Vascular stent thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Biliary cirrhosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.77%
18/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.64%
15/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatitis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatitis alcoholic
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatorenal failure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Jaundice
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Jaundice hepatocellular
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Liver injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abdominal abscess
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abdominal infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Non-alcoholic steatohepatitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Hepatobiliary disorders
Portal hypertension
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Immune system disorders
Allergy to venom
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Immune system disorders
Heart transplant rejection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Immune system disorders
Transplant rejection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abdominal sepsis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abscess intestinal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abscess jaw
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abscess limb
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Abscess oral
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Acinetobacter infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Appendiceal abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Appendicitis
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Appendicitis perforated
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Arthritis infective
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bacteraemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bacterial diarrhoea
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bacterial infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Biliary sepsis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bone abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bone tuberculosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Brain abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bronchitis
|
0.94%
22/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.68%
16/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Burn infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bursitis infective
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Cardiac valve abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Cellulitis
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Cholecystitis infective
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Chronic sinusitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Clostridium difficile infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Corynebacterium infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Cystitis
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Dengue fever
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Device related infection
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Diabetic foot infection
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Diverticulitis
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Dysentery
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Empyema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Encephalitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Endocarditis
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Endocarditis staphylococcal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Enterococcal sepsis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Epididymitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Erysipelas
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Febrile infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Fungal oesophagitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gangrene
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gastric ulcer helicobacter
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.68%
16/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Weight increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gastroenteritis viral
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Genitourinary tract infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
H1N1 influenza
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Haematoma infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Haemophilus sepsis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Hepatic infection bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Hepatitis viral
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Herpes zoster
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Herpes zoster cutaneous disseminated
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Human ehrlichiosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Implant site infection
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Incision site abscess
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Incision site infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infected cyst
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infected seroma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infected skin ulcer
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infection
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infectious colitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Influenza
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Intervertebral discitis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Intestinal sepsis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Localised infection
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Lung infection
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Lyme disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Mycobacterial infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Myiasis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Necrotising fasciitis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Ophthalmic herpes zoster
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Oral infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Complications of transplanted heart
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Orchitis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Oropharyngitis fungal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Otitis media chronic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Parametritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Periodontitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Peritonitis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Peritonitis bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia
|
5.8%
136/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
6.2%
145/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
5.2%
122/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia influenzal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Post procedural infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Post procedural sepsis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Prostatic abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pseudomembranous colitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pseudomonal sepsis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Psoas abscess
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pulmonary sepsis
|
0.34%
8/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pyelonephritis acute
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Suicidal ideation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pyelonephritis chronic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.34%
8/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.64%
15/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.81%
19/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Respiratory tract infection bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Respiratory tract infection fungal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Sepsis
|
0.60%
14/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.77%
18/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Septic necrosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Septic shock
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.89%
21/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Skin bacterial infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Skin infection
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Streptococcal endocarditis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Streptococcal sepsis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Thrombophlebitis septic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Tracheitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Tracheobronchitis
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Urethritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.94%
22/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.89%
21/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.81%
19/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Urosepsis
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Viral pericarditis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Viral vasculitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Wound infection
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Wound infection bacterial
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Wound sepsis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Accident
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Cardiac function disturbance postoperative
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Cardiac procedure complication
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Closed globe injury
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Comminuted fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Periorbital haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Coronary vascular graft occlusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Extradural haematoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Gastrointestinal stoma complication
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Injury
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Intestinal anastomosis complication
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Postoperative hernia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Post thrombotic syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Product name confusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Pulmonary contusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.34%
8/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Sacroiliac fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haemothorax
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Traumatic shock
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Underdose
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Urethral stricture traumatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Vascular bypass dysfunction
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Vasoplegia syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Wound
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Anticoagulation drug level below therapeutic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Anticoagulation drug level increased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood creatinine increased
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood ethanol increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood glucose increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood magnesium decreased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood potassium increased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood urine
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood urine present
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
C-reactive protein increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Cardiac output decreased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Cardioactive drug level increased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Chest X-ray abnormal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Coagulation test abnormal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Coagulation time prolonged
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Ejection fraction abnormal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Ejection fraction decreased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Electrocardiogram QRS complex prolonged
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Enterobacter test positive
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Heart rate decreased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Heart rate irregular
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Hepatic enzyme increased
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
International normalised ratio abnormal
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
International normalised ratio increased
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Lipase increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Oxygen saturation decreased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Transaminases increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Urine output decreased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of spinal cord
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Viral load increased
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Weight decreased
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
White blood cell count increased
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Carbohydrate intolerance
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
27/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.89%
21/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.64%
15/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.68%
16/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Gout
|
0.47%
11/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.89%
21/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.85%
20/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperosmolar hyperglycaemic state
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Marasmus
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Mineral deficiency
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Obesity
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.51%
12/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Connective tissue inflammation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Diabetic amyotrophy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Fracture malunion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondritis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal deformity
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of appendix
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal adenoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ear neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lung neoplasm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign pancreatic neoplasm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder papilloma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone cancer
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm malignant
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer female
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of penis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac valve fibroelastoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellar tumour
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer recurrent
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatobiliary cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypopharyngeal cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine benign neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of auricular cartilage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of renal pelvis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant palate neoplasm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone marrow
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to pleura
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IV
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma stage IV
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pineal parenchymal neoplasm malignant
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.81%
19/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer metastatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland adenoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sinus cancer metastatic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer recurrent
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Complex partial seizures
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Ageusia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Altered state of consciousness
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Aphasia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Atonic seizures
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Basilar artery stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Brain hypoxia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Brain injury
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Brain stem infarction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Brain stem syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Carotid artery disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebellar ataxia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebellar infarction
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral amyloid angiopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral artery embolism
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral atrophy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral haematoma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.38%
9/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.72%
17/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.72%
17/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.9%
44/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.2%
51/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.6%
62/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cervicogenic headache
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Cognitive disorder
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Coma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Dementia
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Diabetic coma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Diabetic hyperosmolar coma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Dizziness
|
0.47%
11/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Dizziness postural
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Dysarthria
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Dyslalia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Embolic stroke
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Encephalomalacia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Epilepsy
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Headache
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hemianopia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hemianopia homonymous
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hydrocephalus
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
IIIrd nerve paresis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Ischaemic stroke
|
1.9%
45/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.9%
45/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.2%
29/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Mental retardation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Monoparesis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Motor neurone disease
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Myoclonus
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Orthostatic intolerance
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Paraparesis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Paresis cranial nerve
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Parkinsonism
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Partial seizures
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Postresuscitation encephalopathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Presyncope
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Retrograde amnesia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Reversible ischaemic neurological deficit
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Sciatica
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Seizure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Syncope
|
2.0%
48/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.4%
56/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.2%
27/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Thalamus haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.98%
23/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.85%
20/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.64%
15/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Tremor
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Vascular encephalopathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Abulia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Acute psychosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Adjustment disorder
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Anxiety
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Anxiety disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Apathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Catatonia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Confusional state
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Delirium
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Delusion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Depression
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Fear
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Major depression
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Schizophrenia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Somatisation disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.2%
52/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.2%
29/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.6%
38/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Anuria
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Azotaemia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Calculus urethral
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.89%
21/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Ischaemic nephropathy
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Polyuria
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Postrenal failure
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Prerenal failure
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal embolism
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal failure
|
1.4%
33/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.1%
26/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.2%
27/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal impairment
|
1.4%
34/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.3%
31/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.4%
33/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal infarct
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Ureteric fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urinary bladder haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.30%
7/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Mammary fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Spermatocele
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.85%
20/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.85%
20/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.72%
17/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.55%
13/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cheyne-Stokes respiration
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
32/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.4%
32/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.8%
43/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Diaphragmatic paralysis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
54/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.0%
46/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.5%
35/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.43%
10/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.51%
12/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurocutaneous fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.26%
6/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.72%
17/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.77%
18/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.38%
9/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haematoma
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.26%
6/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.2%
27/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.1%
27/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.60%
14/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary venous thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.68%
16/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.68%
16/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.1%
26/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Suffocation feeling
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Acquired epidermolysis bullosa
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Fungating wound
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Intertrigo
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Neuropathic ulcer
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Peau d'orange
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Social circumstances
Immobile
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Social circumstances
Treatment noncompliance
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Surgical and medical procedures
Heart transplant
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Accelerated hypertension
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic dilatation
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic dissection
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic rupture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic stenosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Aortic thrombosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Arterial stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Arteriosclerosis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Arteriovenous fistula
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Arteritis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Bleeding varicose vein
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
3/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Extremity necrosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Femoral artery embolism
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Femoral artery occlusion
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Haematoma
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Haemodynamic instability
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypertension
|
0.72%
17/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.43%
10/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypertensive crisis
|
0.30%
7/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypertensive emergency
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypotension
|
1.6%
37/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.1%
49/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
1.1%
26/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypovolaemic shock
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Iliac artery embolism
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Intermittent claudication
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.21%
5/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Ischaemia
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Ischaemic limb pain
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.77%
18/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.55%
13/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.47%
11/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral embolism
|
0.17%
4/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral ischaemia
|
0.21%
5/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.34%
8/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.17%
4/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Secondary hypertension
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Shock
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Thrombophlebitis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Thrombosis
|
0.09%
2/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.09%
2/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Varicophlebitis
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.13%
3/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Vascular rupture
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Venous haemorrhage
|
0.00%
0/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.04%
1/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Venous thrombosis
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.04%
1/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
0.00%
0/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
Other adverse events
| Measure |
Combination of Aliskiren and Enalapril
n=2347 participants at risk
Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
|
Aliskiren
n=2348 participants at risk
Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
|
Enalapril
n=2345 participants at risk
Enalapril monotherapy -10 mg film-coated tablet and administered orally.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
124/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.9%
115/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.7%
111/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Angina pectoris
|
3.5%
81/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.7%
86/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.0%
71/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Atrial fibrillation
|
8.5%
199/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
10.1%
238/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
7.8%
184/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Cardiac failure
|
10.3%
241/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
10.8%
254/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
10.1%
238/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.3%
55/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.2%
74/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.3%
55/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Constipation
|
4.1%
96/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.4%
79/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.5%
82/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
145/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
5.0%
117/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.9%
116/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.9%
68/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.3%
78/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.3%
55/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Fatigue
|
4.1%
96/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.6%
107/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.3%
101/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
General disorders
Oedema peripheral
|
7.8%
182/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
7.8%
183/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
7.5%
176/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Bronchitis
|
6.4%
151/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
5.9%
138/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
6.3%
147/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Influenza
|
3.9%
91/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.6%
62/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.7%
86/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
185/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
8.0%
187/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
7.9%
186/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Pneumonia
|
3.6%
84/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.0%
95/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.3%
78/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.6%
84/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.2%
74/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.4%
79/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
92/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.5%
82/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.6%
84/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Blood creatinine increased
|
4.1%
97/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.0%
70/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.4%
57/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Investigations
Glomerular filtration rate decreased
|
3.7%
88/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.1%
50/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.4%
79/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
4.2%
99/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.1%
96/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.6%
84/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Gout
|
4.8%
113/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.7%
88/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.9%
91/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
20.0%
469/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
12.1%
283/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
14.9%
350/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.3%
101/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.6%
108/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.0%
93/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.5%
130/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
6.3%
149/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.9%
116/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
72/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.7%
86/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.0%
71/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
90/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.5%
82/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.2%
98/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Dizziness
|
7.6%
179/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
6.0%
140/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
6.1%
144/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Nervous system disorders
Headache
|
2.3%
55/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.0%
71/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
2.9%
67/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Psychiatric disorders
Insomnia
|
3.9%
91/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
3.9%
92/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
4.2%
98/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Renal and urinary disorders
Renal impairment
|
17.6%
414/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
12.7%
298/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
14.0%
328/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.1%
285/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
9.5%
223/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
12.2%
286/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.7%
204/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
9.2%
216/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
9.1%
213/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypertension
|
8.0%
188/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
7.7%
180/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
5.8%
137/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
|
Vascular disorders
Hypotension
|
17.4%
409/2347
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
13.1%
308/2348
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
14.2%
332/2345
Safety set (SAF) (double-blind phase) - All patients who received at least one dose of double-blind study drug. Patients were analyzed according to treatment received. Treatment received was considered identical to the randomized treatment if the patient had received at least one dose of the randomized treatment.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER