Trial Outcomes & Findings for Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA) (NCT NCT01897532)
NCT ID: NCT01897532
Last Updated: 2019-04-04
Results Overview
Time to event analysis of patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non-fatal stroke. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE) was reported.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
6991 participants
Primary outcome timeframe
From randomization to individual end of observation; up to 4.3 years
Results posted on
2019-04-04
Participant Flow
Prior to initiation of any trial-related procedure, all patients were informed about the trial verbally and in writing by the investigator. The patients signed and dated the informed consent before any study related procedures.
Patients with documented diagnosis of Type 2 Diabetes Mellitus (T2DM) at high risk of cardiovascular (CV) events and who met all the inclusion criteria and did not meet any of the exclusion criteria could be enrolled in the trial.
Participant milestones
| Measure |
Placebo
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|---|---|---|
|
Discontinuation From Treatment
STARTED
|
3492
|
3499
|
|
Discontinuation From Treatment
Treated
|
3485
|
3494
|
|
Discontinuation From Treatment
COMPLETED
|
2530
|
2660
|
|
Discontinuation From Treatment
NOT COMPLETED
|
962
|
839
|
|
Discontinuation From Trial
STARTED
|
3492
|
3499
|
|
Discontinuation From Trial
Treated
|
3485
|
3494
|
|
Discontinuation From Trial
COMPLETED
|
3430
|
3458
|
|
Discontinuation From Trial
NOT COMPLETED
|
62
|
41
|
Reasons for withdrawal
| Measure |
Placebo
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|---|---|---|
|
Discontinuation From Treatment
Not Treated
|
7
|
5
|
|
Discontinuation From Treatment
Other reason than specified
|
196
|
176
|
|
Discontinuation From Treatment
Withdrawal by Subject
|
333
|
281
|
|
Discontinuation From Treatment
Non compliance
|
24
|
15
|
|
Discontinuation From Treatment
Adverse event/ CV outcome event
|
402
|
362
|
|
Discontinuation From Trial
Not Treated
|
7
|
5
|
|
Discontinuation From Trial
Patient lost to follow-up for MACE
|
55
|
36
|
Baseline Characteristics
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
Baseline characteristics by cohort
| Measure |
Placebo
n=3485 Participants
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
n=3494 Participants
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Total
n=6979 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
66.1 years
STANDARD_DEVIATION 9.05 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 9.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1243 Participants
n=5 Participants
|
1346 Participants
n=7 Participants
|
2589 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2242 Participants
n=5 Participants
|
2148 Participants
n=7 Participants
|
4390 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1274 Participants
n=5 Participants
|
1227 Participants
n=7 Participants
|
2501 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2211 Participants
n=5 Participants
|
2267 Participants
n=7 Participants
|
4478 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
156 Participants
n=5 Participants
|
159 Participants
n=7 Participants
|
315 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
333 Participants
n=5 Participants
|
307 Participants
n=7 Participants
|
640 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
217 Participants
n=5 Participants
|
194 Participants
n=7 Participants
|
411 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2769 Participants
n=5 Participants
|
2827 Participants
n=7 Participants
|
5596 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to individual end of observation; up to 4.3 yearsPopulation: Treated set (TS): All patients treated with at least one dose of trial medication. If no trial medication was taken at site during the visit, but the medication kit was dispensed to the patient and not all trial medication was returned, the patient was included in the TS.
Time to event analysis of patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE): CV death, non-fatal MI or non-fatal stroke. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components of the primary composite endpoint (3-point MACE) was reported.
Outcome measures
| Measure |
Placebo
n=3485 Participants
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
n=3494 Participants
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|---|---|---|
|
Time to the First Occurrence of Any of the Following Adjudication-confirmed Components of the Primary Composite Endpoint 3-point Major Adverse Cardiovascular (CV) Events (3-point MACE): CV Death, Non-fatal Myocardial Infarction (MI) or Non-fatal Stroke.
|
12.1 percentage of participants
|
12.4 percentage of participants
|
SECONDARY outcome
Timeframe: From randomization to individual end of observation; up to 4.3 yearsPopulation: TS
Time to the first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR. The percentage of observed patients with first occurrence of any of the following adjudication-confirmed components: renal death, sustained ESRD, or sustained decrease of 40% or more in eGFR was reported.
Outcome measures
| Measure |
Placebo
n=3485 Participants
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
n=3494 Participants
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|---|---|---|
|
Time to the First Occurrence of Any of the Following Adjudication-confirmed Components: Renal Death, Sustained End Stage Renal Disease (ESRD), or Sustained Decrease of 40% or More in Estimated Glomerular Filtration Rate (eGFR).
|
8.8 percentage of participants
|
9.4 percentage of participants
|
Adverse Events
Placebo
Serious events: 1343 serious events
Other events: 1422 other events
Deaths: 253 deaths
Linagliptin
Serious events: 1293 serious events
Other events: 1434 other events
Deaths: 250 deaths
Serious adverse events
| Measure |
Placebo
n=3485 participants at risk
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
n=3494 participants at risk
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|---|---|---|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Keratosis follicular
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Myocardial bridging
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Death
|
0.66%
23/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.46%
16/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Non-cardiac chest pain
|
0.43%
15/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.43%
15/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Sudden death
|
0.57%
20/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Cardiac death
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Asthenia
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Chest pain
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Pyrexia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Cystocele
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Endometrial hypertrophy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Haemorrhagic ovarian cyst
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Vaginal leukoplakia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Accessory spleen
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pneumonia
|
3.5%
121/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
2.8%
99/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Urinary tract infection
|
1.2%
41/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.86%
30/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Cellulitis
|
1.1%
38/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.63%
22/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Sepsis
|
0.95%
33/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.52%
18/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Bronchitis
|
0.49%
17/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Osteomyelitis
|
0.40%
14/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.31%
11/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Septic shock
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.37%
13/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gangrene
|
0.40%
14/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastroenteritis
|
0.26%
9/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.31%
11/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Localised infection
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pyelonephritis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.40%
14/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Urosepsis
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Respiratory tract infection
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Diabetic foot infection
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Influenza
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pyelonephritis acute
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Erysipelas
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Infected skin ulcer
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Lower respiratory tract infection
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Abscess limb
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Device related infection
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Peritonitis
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Bacteraemia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Necrotising fasciitis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Postoperative wound infection
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Anal abscess
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Catheter site infection
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Diabetic gangrene
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Diverticulitis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Lung infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Post procedural infection
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Appendicitis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Arthritis bacterial
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Clostridium difficile colitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Endocarditis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Escherichia sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pneumonia bacterial
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pulmonary sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Soft tissue infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Bacterial infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Carbuncle
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Cholecystitis infective
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Device related sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Osteomyelitis chronic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Paronychia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Periodontitis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Staphylococcal infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Staphylococcal sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Urinary tract infection fungal
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Wound infection
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Abdominal abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Abdominal sepsis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Abdominal wall abscess
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Bacterial pyelonephritis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Bacterial sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Blebitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Bursitis infective
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Chikungunya virus infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Chronic sinusitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Clostridium colitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Cytomegalovirus infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Dengue fever
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Disseminated tuberculosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Endocarditis bacterial
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Epididymitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Fungal peritonitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastroenteritis shigella
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastrointestinal bacterial infection
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Graft infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Groin abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
H1n1 influenza
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Hepatitis c
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Hepatitis infectious mononucleosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Histoplasmosis cutaneous
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Infected cyst
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Infected dermal cyst
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Infectious colitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Injection site abscess
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Intestinal sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Laryngitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Leptospirosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Liver abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Lyme disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Mediastinitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Medical device site cellulitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Meningitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Mycoplasma infection
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Myiasis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Neutropenic sepsis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Nosocomial infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Orchitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Osteomyelitis viral
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Otitis externa
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Otitis media
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pelvic abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Perineal abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Peritonitis bacterial
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pneumonia chlamydial
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pneumonia legionella
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pulpitis dental
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Pyelonephritis chronic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Renal abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Respiratory tract infection viral
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Sialoadenitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Skin infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Spinal cord abscess
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Systemic infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Tooth infection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Tuberculosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Viraemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.40%
14/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.40%
14/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.26%
9/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-hodgkin's lymphoma
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign ovarian tumour
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mediastinum neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute monocytic leukaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute promyelocytic leukaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basosquamous carcinoma of skin
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of penis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac neoplasm unspecified
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chest wall tumour
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Cystic lymphangioma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder cancer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyosarcoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm malignant stage unspecified
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage 0
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant anorectal neoplasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic carcinoma of the bladder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mucinous cystadenocarcinoma of pancreas
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Naevoid melanoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma recurrent
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Penile squamous cell carcinoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Schwannoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Sebaceous adenoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue cancer recurrent
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour of ampulla of vater
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vulval cancer stage 0
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Anaemia
|
0.49%
17/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.54%
19/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Immune system disorders
Overlap syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Endocrine disorders
Goitre
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Endocrine disorders
Adrenal mass
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Endocrine disorders
Hypothyroidism
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
38/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.80%
28/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.55%
19/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.46%
16/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.63%
22/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.34%
12/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.31%
11/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.29%
10/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.32%
11/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Gout
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Acquired mixed hyperlipidaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperosmolar state
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Obesity
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Vitamin d deficiency
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Delirium
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Major depression
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Mental status changes
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Depression
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Anxiety
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Confusional state
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Hallucination, visual
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Acute stress disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Completed suicide
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Drug use disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Insomnia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Irritability
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Psychotic disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Psychiatric disorders
Suicidal ideation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Ischaemic stroke
|
1.4%
49/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
1.7%
61/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Syncope
|
0.72%
25/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.43%
15/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
9/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.77%
27/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebrovascular accident
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Dementia
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Diabetic neuropathy
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Seizure
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Presyncope
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Carotid artery stenosis
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebral ischaemia
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Facial paralysis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Headache
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Loss of consciousness
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Encephalopathy
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Hemiparesis
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Myelopathy
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Altered state of consciousness
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Diabetic coma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Epilepsy
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Lacunar infarction
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Basal ganglia infarction
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Brain oedema
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Brain stem infarction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Carotid artery occlusion
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebrovascular disorder
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Dementia with lewy bodies
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Embolic stroke
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Facial nerve disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Hypoglycaemic coma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Parkinson's disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Thrombotic stroke
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Brain injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Carotid arteriosclerosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Carotid artery dissection
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Central nervous system lesion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebral haematoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebral small vessel ischaemic disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cervical radiculopathy
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Coma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Complex regional pain syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Dyskinesia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Incoherent
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Lacunar stroke
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Multiple sclerosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Myasthenia gravis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Neuritis cranial
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Neuroglycopenia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Parkinsonism
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Polyneuropathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Post stroke seizure
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Spinal claudication
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Spinal epidural haematoma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Thalamic infarction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Tremor
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Uraemic encephalopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Vascular headache
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Vith nerve paralysis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Nervous system disorders
Wernicke's encephalopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Cataract
|
0.37%
13/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.31%
11/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Glaucoma
|
0.26%
9/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Vitreous haemorrhage
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinal detachment
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Diabetic retinopathy
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Macular hole
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinal vein occlusion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Ulcerative keratitis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Diplopia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Macular degeneration
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Angle closure glaucoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Macular fibrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Neovascular age-related macular degeneration
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinal haemorrhage
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Acquired corneal dystrophy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Amaurosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Amaurosis fugax
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Blindness
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Cataract cortical
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Corneal decompensation
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Diabetic retinal oedema
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Dry age-related macular degeneration
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Hyalosis asteroid
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Macular oedema
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Open angle glaucoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Optic ischaemic neuropathy
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinal artery embolism
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinal degeneration
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Retinopathy
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Uveitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Eye disorders
Vitreous haematoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Vertigo
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Deafness
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Deafness bilateral
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Tinnitus
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Conductive deafness
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac failure
|
3.0%
104/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
3.0%
104/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac failure congestive
|
2.8%
98/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
2.2%
77/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Angina unstable
|
2.0%
70/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
2.2%
77/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Acute myocardial infarction
|
1.7%
59/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
2.2%
78/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Myocardial infarction
|
1.5%
54/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
1.3%
47/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Angina pectoris
|
0.72%
25/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
1.2%
42/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.75%
26/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.97%
34/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Coronary artery disease
|
0.60%
21/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.74%
26/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac failure chronic
|
0.57%
20/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.69%
24/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac arrest
|
0.49%
17/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.72%
25/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.57%
20/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.52%
18/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.34%
12/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Left ventricular failure
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.37%
13/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Atrial flutter
|
0.32%
11/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.37%
13/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiogenic shock
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Atrioventricular block complete
|
0.29%
10/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Bradycardia
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Sinus node dysfunction
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Acute left ventricular failure
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Atrioventricular block
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Ventricular fibrillation
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Arrhythmia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Aortic valve incompetence
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Bundle branch block left
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiomegaly
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Diastolic dysfunction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Myocardial fibrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Silent myocardial infarction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Systolic dysfunction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Adams-stokes syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Aortic valve disease
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Arrhythmia supraventricular
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiomyopathy acute
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiorenal syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cardiovascular disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Chordae tendinae rupture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Chronic left ventricular failure
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Degenerative mitral valve disease
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Intracardiac thrombus
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Mitral valve disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Mitral valve stenosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Myocardial necrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Myocarditis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Paroxysmal atrioventricular block
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Pericarditis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Pericarditis constrictive
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Pulseless electrical activity
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Sinus arrest
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Tachycardia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Hypertension
|
0.52%
18/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.92%
32/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Hypertensive crisis
|
0.57%
20/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.46%
16/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.49%
17/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.52%
18/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.40%
14/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.34%
12/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral artery occlusion
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral ischaemia
|
0.32%
11/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Aortic stenosis
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral vascular disorder
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Extremity necrosis
|
0.26%
9/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Hypotension
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral artery stenosis
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Aortic aneurysm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Hypovolaemic shock
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Venous thrombosis limb
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Arteriosclerosis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Hypertensive emergency
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Circulatory collapse
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Accelerated hypertension
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Angiopathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Diabetic macroangiopathy
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Dry gangrene
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Haematoma
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral embolism
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Thrombophlebitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Varicose ulceration
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Aortic thrombosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Arterial insufficiency
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Arterial rupture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Arteriovenous fistula
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Blood pressure inadequately controlled
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Diabetic vascular disorder
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Distributive shock
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Embolism
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Embolism arterial
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Embolism venous
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Femoral artery aneurysm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Iliac artery occlusion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Orthostatic hypertension
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Peripheral venous disease
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Shock
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Systolic hypertension
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Thrombosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Vascular insufficiency
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Vein rupture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.80%
28/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.60%
21/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.46%
16/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.46%
16/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.37%
13/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.46%
16/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.43%
15/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.37%
13/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.40%
14/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.37%
13/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.40%
14/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.34%
12/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.34%
12/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.32%
11/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.32%
11/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal mass
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Mendelson's syndrome
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Paraneoplastic pleural effusion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural thickening
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Portopulmonary hypertension
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Sinus polyp
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord cyst
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.32%
11/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.23%
8/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Vomiting
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.17%
6/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Constipation
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Haematochezia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Duodenitis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Ascites
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Enterocolitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastric polyps
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Ileus
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Incarcerated inguinal hernia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Intestinal haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Mesenteric artery thrombosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Nausea
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Anal fistula
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Anal polyp
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Diverticulum
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Duodenal vascular ectasia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Duodenitis haemorrhagic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Enterocolitis haemorrhagic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Faecaloma
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastric antral vascular ectasia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastritis haemorrhagic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Lip ulceration
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Mechanical ileus
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Mesenteric haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Oedema mouth
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Rectal polyp
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Retroperitoneal fibrosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Strangulated umbilical hernia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Gastrointestinal disorders
Vomiting projectile
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
9/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Hepatic failure
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Bile duct stone
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cholangitis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Biliary dyspepsia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Cirrhosis alcoholic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Portal hypertension
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.69%
24/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.60%
21/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.29%
10/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Ichthyosis acquired
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Necrobiosis lipoidica diabeticorum
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Skin necrosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Skin ulcer haemorrhage
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.49%
17/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.43%
15/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Diabetic arthropathy
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis reactive
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy toxic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Neuropathic arthropathy
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Musculoskeletal and connective tissue disorders
Vertebral osteophyte
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
100/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
2.7%
96/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
End stage renal disease
|
1.3%
45/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
1.1%
38/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.92%
32/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
1.4%
49/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal failure
|
0.89%
31/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.92%
32/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal impairment
|
0.77%
27/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.69%
24/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.26%
9/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Urinary retention
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Haematuria
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.20%
7/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Azotaemia
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Nephropathy
|
0.11%
4/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal colic
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal mass
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Acute prerenal failure
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Anuria
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Bladder prolapse
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Dysuria
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Glomerulonephritis membranous
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Hypertensive nephropathy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Oliguria
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Proteinuria
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal disorder
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Renal and urinary disorders
Urinary incontinence
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.23%
8/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Generalised oedema
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Oedema peripheral
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Sudden cardiac death
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Chest discomfort
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Vascular stent restenosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Catheter site haemorrhage
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Chills
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Complication associated with device
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
General physical health deterioration
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Necrobiosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Application site haemorrhage
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Chronic fatigue syndrome
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Fatigue
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Feeling abnormal
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Impaired healing
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Injection site haematoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Malaise
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Medical device site joint inflammation
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Peripheral swelling
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Strangulated hernia
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
General disorders
Vascular stent occlusion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Glomerular filtration rate decreased
|
0.86%
30/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
1.0%
36/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Lipase increased
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Blood creatinine increased
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Blood pressure increased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Arteriogram coronary
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Blood glucose increased
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Glycosylated haemoglobin increased
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Troponin increased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Alanine aminotransferase increased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Aspartate aminotransferase increased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Aspiration bronchial
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Catheterisation cardiac
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Creatinine renal clearance decreased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Echocardiogram
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Electrocardiogram qt prolonged
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Electrocardiogram t wave inversion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Influenza a virus test positive
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
International normalised ratio increased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Intracardiac pressure increased
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Liver function test abnormal
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Liver function test increased
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Prostatic specific antigen increased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Staphylococcus test positive
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Urine output decreased
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.72%
25/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.54%
19/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.17%
6/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.29%
10/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.14%
5/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.20%
7/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.11%
4/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.14%
5/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Head injury
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.09%
3/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Overdose
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.09%
3/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Back injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Hyphaema
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Anastomotic complication
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Colon injury
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Endotracheal intubation complication
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Fracture displacement
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Heart injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Incomplete spinal fusion
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Laceration
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Peritoneal dialysis complication
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Procedural hypotension
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Scar
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Skull fractured base
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Stoma site polyp
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Stomal hernia
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Traumatic liver injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Vith nerve injury
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Wound
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Surgical and medical procedures
Hospitalisation
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Social circumstances
Homicide
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Social circumstances
Limb prosthesis user
|
0.00%
0/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.03%
1/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Product Issues
Device malfunction
|
0.06%
2/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.06%
2/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Product Issues
Device failure
|
0.03%
1/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
0.00%
0/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
Other adverse events
| Measure |
Placebo
n=3485 participants at risk
Patients were administered Placebo matching Linagliptin 5 mg film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
Linagliptin
n=3494 participants at risk
Patients were administered Linagliptin 5 milligram (mg) film-coated tablet orally once daily.
At Visit 2, patients received one treatment box sufficient for 12 weeks treatment (plus 1 week reserve).
At Visit 3 (until trial end) patients received 2 medication boxes sufficient for 24 weeks treatment (plus 2 weeks reserve).
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
4.6%
162/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
5.6%
196/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
28.8%
1003/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
29.3%
1022/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.9%
240/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
6.0%
208/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Vascular disorders
Hypertension
|
6.7%
232/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
6.2%
216/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
|
Investigations
Glomerular filtration rate decreased
|
5.7%
200/3485 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
5.8%
202/3494 • Adverse events with an onset after the first dose of trial medication up to a period of 7 days after the last permanent study drug stop; up to 4.3 years
|
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER