Trial Outcomes & Findings for Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension (NCT NCT00660179)
NCT ID: NCT00660179
Last Updated: 2015-09-28
Results Overview
Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH). Other worsening of PAH was defined by the combined occurrence of all the following 3 events: At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks. AND worsening of PAH symptoms including at least one of the following: a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
742 participants
Primary outcome timeframe
Up to end of treatment (data presented up to month 36)
Results posted on
2015-09-28
Participant Flow
A total of 955 patients were screened from 158 centers in 39 countries, and 742 patients from 151 centers in 39 countries were randomized
Participant milestones
| Measure |
Placebo
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
242
|
|
Overall Study
COMPLETED
|
194
|
192
|
201
|
|
Overall Study
NOT COMPLETED
|
56
|
58
|
41
|
Reasons for withdrawal
| Measure |
Placebo
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Overall Study
Death
|
44
|
47
|
34
|
|
Overall Study
Withdrawal of consent
|
4
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
7
|
5
|
2
|
|
Overall Study
Administrative reason
|
0
|
0
|
1
|
|
Overall Study
Incorrect randomization
|
1
|
0
|
0
|
Baseline Characteristics
Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Placebo
n=250 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
Total
n=742 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
6 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
199 participants
n=5 Participants
|
208 participants
n=7 Participants
|
209 participants
n=5 Participants
|
616 participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
43 participants
n=5 Participants
|
33 participants
n=7 Participants
|
27 participants
n=5 Participants
|
103 participants
n=4 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 17.03 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 16.26 • n=7 Participants
|
45.5 years
STANDARD_DEVIATION 14.99 • n=5 Participants
|
45.6 years
STANDARD_DEVIATION 16.13 • n=4 Participants
|
|
Gender
Female
|
184 participants
n=5 Participants
|
187 participants
n=7 Participants
|
194 participants
n=5 Participants
|
565 participants
n=4 Participants
|
|
Gender
Male
|
65 participants
n=5 Participants
|
61 participants
n=7 Participants
|
48 participants
n=5 Participants
|
174 participants
n=4 Participants
|
|
Region of Enrollment
Argentina
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
13 participants
n=5 Participants
|
43 participants
n=4 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
4 participants
n=5 Participants
|
10 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Belarus
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
8 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Bulgaria
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Chile
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
9 participants
n=5 Participants
|
28 participants
n=4 Participants
|
|
Region of Enrollment
China
|
31 participants
n=5 Participants
|
29 participants
n=7 Participants
|
27 participants
n=5 Participants
|
87 participants
n=4 Participants
|
|
Region of Enrollment
Colombia
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
9 participants
n=4 Participants
|
|
Region of Enrollment
Croatia
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Denmark
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
France
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
11 participants
n=4 Participants
|
|
Region of Enrollment
Germany
|
17 participants
n=5 Participants
|
14 participants
n=7 Participants
|
13 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Region of Enrollment
Hong Kong
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Region of Enrollment
Hungary
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
India
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
15 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
Region of Enrollment
Israel
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
8 participants
n=5 Participants
|
20 participants
n=4 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
Malaysia
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Mexico
|
13 participants
n=5 Participants
|
13 participants
n=7 Participants
|
14 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Region of Enrollment
Norway
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
|
Region of Enrollment
Peru
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
7 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Romania
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Russian Federation
|
25 participants
n=5 Participants
|
24 participants
n=7 Participants
|
23 participants
n=5 Participants
|
72 participants
n=4 Participants
|
|
Region of Enrollment
Serbia
|
7 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
16 participants
n=4 Participants
|
|
Region of Enrollment
Singapore
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
4 participants
n=5 Participants
|
13 participants
n=4 Participants
|
|
Region of Enrollment
Slovakia
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Region of Enrollment
South Africa
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
8 participants
n=5 Participants
|
24 participants
n=4 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
6 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Region of Enrollment
Sweden
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
Taiwan
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
Region of Enrollment
Thailand
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Turkey
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
25 participants
n=7 Participants
|
19 participants
n=5 Participants
|
67 participants
n=4 Participants
|
|
Region of Enrollment
Ukraine
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
|
World Health Organisation Functional Class
Class I
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
World Health Organisation Functional Class
Class II
|
129 participants
n=5 Participants
|
138 participants
n=7 Participants
|
120 participants
n=5 Participants
|
387 participants
n=4 Participants
|
|
World Health Organisation Functional Class
Class III
|
116 participants
n=5 Participants
|
105 participants
n=7 Participants
|
116 participants
n=5 Participants
|
337 participants
n=4 Participants
|
|
World Health Organisation Functional Class
Class IV
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
14 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to end of treatment (data presented up to month 36)Population: All randomized patients
Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH). Other worsening of PAH was defined by the combined occurrence of all the following 3 events: At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks. AND worsening of PAH symptoms including at least one of the following: a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics
Outcome measures
| Measure |
Placebo
n=250 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
Kaplan-Meier estimate at Month 6
|
80.1 percentage of participants-Kaplan Meier
|
89.3 percentage of participants-Kaplan Meier
|
92.7 percentage of participants-Kaplan Meier
|
|
Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
Kaplan-Meier estimate at Month 12
|
71.4 percentage of participants-Kaplan Meier
|
81.6 percentage of participants-Kaplan Meier
|
85.5 percentage of participants-Kaplan Meier
|
|
Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
Kaplan-Meier estimate at Month 18
|
61.5 percentage of participants-Kaplan Meier
|
72.5 percentage of participants-Kaplan Meier
|
79.9 percentage of participants-Kaplan Meier
|
|
Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
Kaplan-Meier estimate at Month 24
|
57.3 percentage of participants-Kaplan Meier
|
65.5 percentage of participants-Kaplan Meier
|
74.3 percentage of participants-Kaplan Meier
|
|
Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
Kaplan-Meier estimate at Month 30
|
50.2 percentage of participants-Kaplan Meier
|
61.9 percentage of participants-Kaplan Meier
|
70.0 percentage of participants-Kaplan Meier
|
|
Time to First Confirmed Morbidity or Mortality Event up to the End of Treatment (Kaplan-Meier Estimate of Patients Without a Morbidity or Mortality Event)
Kaplan-Meier estimate at Month 36
|
47.0 percentage of participants-Kaplan Meier
|
55.0 percentage of participants-Kaplan Meier
|
63.2 percentage of participants-Kaplan Meier
|
SECONDARY outcome
Timeframe: Up to end of treatment (data presented up to month 36)Population: All randomized patients
Events of PAH or hospitalization for PAH up to the end of treatment included: death due to PAH, or onset of a treatment-emergent adverse event with a fatal outcome due to PAH occurring up to 4 weeks after the end of treatment, or hospitalisation for PAH up to the end of treatment.
Outcome measures
| Measure |
Placebo
n=250 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 6
|
84.8 percentage of participants-Kaplan Meier
|
90.8 percentage of participants-Kaplan Meier
|
94.6 percentage of participants-Kaplan Meier
|
|
Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 12
|
76.7 percentage of participants-Kaplan Meier
|
84.9 percentage of participants-Kaplan Meier
|
89.8 percentage of participants-Kaplan Meier
|
|
Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 18
|
69.0 percentage of participants-Kaplan Meier
|
78.1 percentage of participants-Kaplan Meier
|
84.8 percentage of participants-Kaplan Meier
|
|
Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 24
|
67.9 percentage of participants-Kaplan Meier
|
75.1 percentage of participants-Kaplan Meier
|
81.7 percentage of participants-Kaplan Meier
|
|
Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 30
|
62.0 percentage of participants-Kaplan Meier
|
70.3 percentage of participants-Kaplan Meier
|
77.9 percentage of participants-Kaplan Meier
|
|
Time to Death Due to PAH or Hospitalisation for PAH up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 36
|
55.4 percentage of participants-Kaplan Meier
|
67.1 percentage of participants-Kaplan Meier
|
70.6 percentage of participants-Kaplan Meier
|
SECONDARY outcome
Timeframe: Up to end of treatment (data presented up to month 36)Population: All randomized patients
Events of death due to any cause up to the end of treatment (plus 7 days)
Outcome measures
| Measure |
Placebo
n=250 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 6
|
95.2 percentage of participants-Kaplan Meier
|
97.1 percentage of participants-Kaplan Meier
|
97.4 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 12
|
93.6 percentage of participants-Kaplan Meier
|
95.6 percentage of participants-Kaplan Meier
|
96.4 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 18
|
92.4 percentage of participants-Kaplan Meier
|
94.6 percentage of participants-Kaplan Meier
|
94.8 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 24
|
91.7 percentage of participants-Kaplan Meier
|
91.7 percentage of participants-Kaplan Meier
|
94.8 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 30
|
89.8 percentage of participants-Kaplan Meier
|
89.9 percentage of participants-Kaplan Meier
|
93.3 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Treatment (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 36
|
89.8 percentage of participants-Kaplan Meier
|
87.3 percentage of participants-Kaplan Meier
|
93.3 percentage of participants-Kaplan Meier
|
SECONDARY outcome
Timeframe: Up to end of study (data presented up to month 36)Population: All randomized patients
Events of death due to any cause up to the end of study (EOS). The initiation of EOS procedure occurred when the target of 285 events was expected to have been achieved (30 January 2012).
Outcome measures
| Measure |
Placebo
n=250 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 6
|
94.7 percentage of participants-Kaplan Meier
|
96.4 percentage of participants-Kaplan Meier
|
96.3 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 12
|
91.4 percentage of participants-Kaplan Meier
|
93.9 percentage of participants-Kaplan Meier
|
95.0 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 18
|
89.3 percentage of participants-Kaplan Meier
|
91.4 percentage of participants-Kaplan Meier
|
93.3 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 24
|
87.2 percentage of participants-Kaplan Meier
|
87.3 percentage of participants-Kaplan Meier
|
89.1 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 30
|
82.6 percentage of participants-Kaplan Meier
|
83.4 percentage of participants-Kaplan Meier
|
86.9 percentage of participants-Kaplan Meier
|
|
Time to Death Due to Any Cause up to the End of Study (Kaplan-Meier Estimate of Patients Without an Event)
Kaplan-Meier Estimate at Month 36
|
80.7 percentage of participants-Kaplan Meier
|
80.0 percentage of participants-Kaplan Meier
|
82.9 percentage of participants-Kaplan Meier
|
SECONDARY outcome
Timeframe: Baseline to month 6Population: All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis
The 6-minute walk test (6MWT) is a non-encouraged test, performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. These guidelines were provided to all sites. For patients who had never performed a 6MWT previously, a training test was required before the qualifying tests for inclusion were performed.
Outcome measures
| Measure |
Placebo
n=249 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=248 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Change From Baseline to Month 6 in 6-minute Walk Distance
Baseline
|
352 metres
Standard Deviation 110.6
|
364 metres
Standard Deviation 95.5
|
363 metres
Standard Deviation 93.2
|
|
Change From Baseline to Month 6 in 6-minute Walk Distance
Change from baseline at Month 6
|
-9.4 metres
Standard Deviation 100.59
|
7.4 metres
Standard Deviation 93.15
|
12.5 metres
Standard Deviation 83.54
|
SECONDARY outcome
Timeframe: Baseline to month 6Population: All randomized patients excluding 1 patient in the placebo group who did not start study treatment and 2 patients in the ACT-064992 3 mg group who did not follow appropriate consent procedures and were not included in the analysis
Class I: no limitation of usual physical activity (PA) which does not increase dyspnea, fatigue, chest pain, or presyncope. Class II: mild limitation of PA. No discomfort at rest. Normal PA increases dyspnea, fatigue, chest pain, or presyncope. Class III: marked limitation of PA. No discomfort at rest. Less than ordinary activity increases dyspnea, fatigue, chest pain, or presyncope. Class IV: unable to perform any PA and who may have signs of right ventricular failure. Dyspnea and/or fatigue may be present at rest and symptoms are increased by almost any PA.
Outcome measures
| Measure |
Placebo
n=249 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=248 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Number of Patients With Improvements in World Health Organization Functional Class From Baseline to Month 6
|
32 participants
|
49 participants
|
54 participants
|
SECONDARY outcome
Timeframe: Baseline to month 6Population: All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study
In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.
Outcome measures
| Measure |
Placebo
n=50 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=47 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=48 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Pulmonary Vascular Resistance at Baseline and Month 6
Baseline
|
886 (dyn*sec/cm^5)
Full Range 587 • Interval 259.0 to 3390.0
|
945 (dyn*sec/cm^5)
Full Range 541 • Interval 250.0 to 2317.0
|
907 (dyn*sec/cm^5)
Full Range 550 • Interval 254.0 to 2279.0
|
|
Pulmonary Vascular Resistance at Baseline and Month 6
Month 6
|
1042 (dyn*sec/cm^5)
Full Range 656 • Interval 164.0 to 3409.0
|
736 (dyn*sec/cm^5)
Full Range 434 • Interval 71.0 to 2308.0
|
680 (dyn*sec/cm^5)
Full Range 497 • Interval 158.0 to 2813.0
|
SECONDARY outcome
Timeframe: Baseline to month 6Population: All randomized patients participating in the pharmacokinetic/pharmacodynamic sub-study
In a sub-study, hemodynamic variables were assessed at baseline and Month 6. If the patient had undergone a right heart catheterization during the 3 months prior to randomization, these results were to be used as baseline values, if the background therapy had not changed during the intervening period.
Outcome measures
| Measure |
Placebo
n=50 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=47 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=48 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Cardiac Index at Baseline and Month 6
Baseline
|
2.54 L/min/m^2
Interval 1.31 to 4.54
|
2.34 L/min/m^2
Interval 1.13 to 5.15
|
2.63 L/min/m^2
Interval 1.2 to 6.24
|
|
Cardiac Index at Baseline and Month 6
Month 6
|
2.21 L/min/m^2
Interval 1.06 to 3.89
|
2.69 L/min/m^2
Interval 1.26 to 5.59
|
2.93 L/min/m^2
Interval 1.46 to 5.11
|
|
Cardiac Index at Baseline and Month 6
Change from Baseline to Month 6
|
-0.33 L/min/m^2
Interval -2.53 to 0.44
|
0.36 L/min/m^2
Interval -0.81 to 1.76
|
0.30 L/min/m^2
Interval -2.97 to 1.99
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to end of treatment (Up to 36 months)Population: All randomized patients
Morbidity or mortality events were defined as: a) Death; b) Atrial septostomy; c) Lung transplantation; d) Initiation of intravenous (i.v.) or subcutaneous prostanoids, or; e) Other worsening of pulmonary arterial hypertension (PAH). Other worsening of PAH was defined by the combined occurrence of all the following 3 events: At least 15% decrease in the 6 minute walk distance from baseline, confirmed by 2 tests performed on separate days, within 2 weeks. AND worsening of PAH symptoms including at least one of the following: a) Increase in WHO Functional Class (WHO FC), or no change in patients in WHO FC IV at baseline; b) Appearance or worsening of signs of right heart failure that did not respond to optimized oral diuretic therapy AND need for new treatment(s) for PAH that included the following: a) Oral or inhaled prostanoids; b) Oral phosphodiesterase inhibitors; c) Endothelin receptor antagonists (only after discontinuation of study treatment; d) i.v. diuretics
Outcome measures
| Measure |
Placebo
n=250 Participants
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 Participants
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 Participants
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Summary of the First Causes of Morbidity or Mortality
Other worsening of PAH
|
93 participants
|
72 participants
|
59 participants
|
|
Summary of the First Causes of Morbidity or Mortality
Death
|
17 participants
|
21 participants
|
16 participants
|
|
Summary of the First Causes of Morbidity or Mortality
Prostanoid initiation (i.v. or s.c.)
|
6 participants
|
1 participants
|
1 participants
|
|
Summary of the First Causes of Morbidity or Mortality
Lung transplantation
|
0 participants
|
1 participants
|
0 participants
|
Adverse Events
Placebo
Serious events: 137 serious events
Other events: 219 other events
Deaths: 0 deaths
ACT-064992 3 mg
Serious events: 130 serious events
Other events: 227 other events
Deaths: 0 deaths
ACT-064992 10 mg
Serious events: 109 serious events
Other events: 222 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=249 participants at risk
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 participants at risk
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 participants at risk
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERIAL HYPERTENSION
|
22.5%
56/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
19.2%
48/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
13.2%
32/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
1.6%
4/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.6%
4/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL CYST
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
TACHYPNOEA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
16.1%
40/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
8.4%
21/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
9.5%
23/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.7%
4/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
CARDIAC ARREST
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
BRADYCARDIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.2%
3/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
LEFT VENTRICULAR FAILURE
|
1.2%
3/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ACUTE RIGHT VENTRICULAR FAILURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
PALPITATIONS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
RIGHT VENTRICULAR DYSFUNCTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
ACUTE LEFT VENTRICULAR FAILURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
TACHYARRHYTHMIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PNEUMONIA
|
3.2%
8/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.8%
7/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.7%
4/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
GASTROENTERITIS
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
BRONCHITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.2%
3/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
ERYSIPELAS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
SEPSIS
|
1.6%
4/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
LUNG INFECTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
SEPTIC SHOCK
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
WOUND INFECTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
BRONCHITIS BACTERIAL
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
DIARRHOEA INFECTIOUS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
HEPATITIS E
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
LUNG INFECTION PSEUDOMONAL
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
OMPHALITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
OVERGROWTH BACTERIAL
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PAROTID ABSCESS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PNEUMONIA INFLUENZAL
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PNEUMONIA MORAXELLA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
POST PROCEDURAL CELLULITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PYELONEPHRITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
SALPINGO-OOPHORITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
SIALOADENITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
TRACHEOBRONCHITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
VULVAL ABSCESS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
CELLULITIS
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
ABSCESS INTESTINAL
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
APPENDICITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
CUTANEOUS TUBERCULOSIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
HERPES ZOSTER
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
SINUSITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
ASCITES
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
ANAL POLYP
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
GASTROINTESTINAL MOTILITY DISORDER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
MALABSORPTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
PANCREATITIS RELAPSING
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
TONGUE HAEMORRHAGE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
ILEUS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
PANCREATIC MASS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
PERITONITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
CHEST PAIN
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.6%
4/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.2%
3/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
PYREXIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
ADVERSE DRUG REACTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
DEATH
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
CHEST DISCOMFORT
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
DEVICE MALFUNCTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
FATIGUE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
MULTI-ORGAN DISORDER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
DEVICE DISLOCATION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
OEDEMA PERIPHERAL
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
SYNCOPE
|
2.4%
6/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.8%
7/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.7%
4/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
SCIATICA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
PRESYNCOPE
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
TRIGEMINAL NEURALGIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.0%
5/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.5%
6/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
HAEMOLYTIC ANAEMIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
HYPOCOAGULABLE STATE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
ANAEMIA MEGALOBLASTIC
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN NEOPLASM
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ANGIOSARCOMA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTOSIGMOID CANCER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TONGUE NEOPLASM BENIGN
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
OVARIAN CYST
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
PELVIC FLUID COLLECTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
POSTMENOPAUSAL HAEMORRHAGE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Reproductive system and breast disorders
UTERINE HAEMORRHAGE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
HEPATITIS B VIRUS TEST POSITIVE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
HIV TEST POSITIVE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
INTERNATIONAL NORMALISED RATIO DECREASED
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
BRAIN CONTUSION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
BRAIN HERNIATION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
PATELLA FRACTURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Injury, poisoning and procedural complications
TRAUMATIC BRAIN INJURY
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC SCLEROSIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.83%
2/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROTIC FRACTURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
1.6%
4/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
LUPUS NEPHRITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
TUBULOINTERSTITIAL NEPHRITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
PROTEINURIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
RENAL COLIC
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
HEPATITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
JAUNDICE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
ISCHAEMIC HEPATITIS
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
LIVER INJURY
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
HEPATIC CIRRHOSIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Hepatobiliary disorders
POST CHOLECYSTECTOMY SYNDROME
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Pregnancy, puerperium and perinatal conditions
PREGNANCY
|
0.80%
2/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.0%
5/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Pregnancy, puerperium and perinatal conditions
COMPLICATION OF PREGNANCY
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
HYPOTENSION
|
1.2%
3/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
HYPOVOLAEMIC SHOCK
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
ARTERIOVENOUS FISTULA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
VASCULITIS NECROTISING
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
GOUT
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Psychiatric disorders
ALCOHOLISM
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Psychiatric disorders
MENTAL DISORDER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Psychiatric disorders
DRUG ABUSE
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.80%
2/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
LEUKOCYTOCLASTIC VASCULITIS
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Skin and subcutaneous tissue disorders
PURPURA
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Surgical and medical procedures
CARDIAC PACEMAKER INSERTION
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Surgical and medical procedures
HEART AND LUNG TRANSPLANT
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.40%
1/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Congenital, familial and genetic disorders
GLYCOGEN STORAGE DISEASE TYPE V
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.40%
1/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Eye disorders
GLAUCOMA
|
0.00%
0/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.00%
0/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
0.41%
1/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
Other adverse events
| Measure |
Placebo
n=249 participants at risk
Matching ACT-064992 placebo tablet, once daily
|
ACT-064992 3 mg
n=250 participants at risk
ACT-064992 tablet, 3 mg, once daily
|
ACT-064992 10 mg
n=242 participants at risk
ACT-064992 tablet, 10 mg, once daily
|
|---|---|---|---|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
12.9%
32/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
19.2%
48/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
15.3%
37/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
OEDEMA PERIPHERAL
|
18.1%
45/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
16.0%
40/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
18.2%
44/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.4%
26/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
14.8%
37/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
14.0%
34/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
HEADACHE
|
8.8%
22/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
13.2%
33/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
13.2%
32/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ARTERIAL HYPERTENSION
|
13.3%
33/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
11.6%
29/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
11.2%
27/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
DIZZINESS
|
10.8%
27/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
9.6%
24/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
10.7%
26/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Blood and lymphatic system disorders
ANAEMIA
|
2.8%
7/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
7.2%
18/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
12.4%
30/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
BRONCHITIS
|
5.2%
13/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
7.6%
19/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
11.2%
27/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
12.0%
30/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
8.0%
20/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
8.7%
21/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
8.4%
21/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
9.6%
24/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.6%
16/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
CHEST PAIN
|
7.6%
19/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
7.2%
18/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
7.0%
17/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
DIARRHOEA
|
6.4%
16/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.6%
14/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
8.7%
21/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
URINARY TRACT INFECTION
|
4.4%
11/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.4%
16/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
7.9%
19/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Psychiatric disorders
INSOMNIA
|
4.0%
10/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.8%
17/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
7.0%
17/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
5.6%
14/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.2%
13/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.8%
14/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Vascular disorders
HYPOTENSION
|
3.2%
8/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.2%
13/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.8%
14/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
7.2%
18/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.4%
16/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.1%
10/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
3.6%
9/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.0%
15/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.5%
11/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
PHARYNGITIS
|
2.8%
7/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.4%
11/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.2%
15/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Cardiac disorders
PALPITATIONS
|
5.2%
13/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.2%
13/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.0%
12/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
INFLUENZA
|
1.6%
4/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.4%
11/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.8%
14/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
8.4%
21/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.0%
15/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
3.7%
9/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
NAUSEA
|
5.2%
13/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.8%
12/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
5.0%
12/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION VIRAL
|
3.6%
9/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
3.6%
9/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.2%
15/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Nervous system disorders
SYNCOPE
|
6.8%
17/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
6.0%
15/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
3.3%
8/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
General disorders
FATIGUE
|
6.0%
15/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.4%
11/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
3.3%
8/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
VOMITING
|
6.8%
17/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.8%
7/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.1%
10/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Gastrointestinal disorders
DYSPEPSIA
|
5.6%
14/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.0%
10/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.9%
7/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.6%
14/249 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
4.0%
10/250 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
2.9%
7/242 • Up to end of treatment plus 28 days (Up to approximately 36 months)
One patient in the placebo group never received study treatment and was not included in the analysis. Adverse events during treatment period and up to 28 days after treatment discontinuation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60